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Collection details per study
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AEO
Archipelago
AtheroMaas
Biobank Huntington
BRIMM-HUM Study
Cardiale Amyloidose
Chloroquine GBM
CVRM na PE
ELDAPT
EMPA-MVD
Endoscope CRC Cohort
EORTC Prostaat
Eye Tissue Bank Maastricht
FORCE-NEN
Frailty in Uremia
HealthySauna
HN Tumor Biobank
IPON-1
L19-IL2
Nelfinavir GBM
Nelfinavir rectum
NVALT28
OPTIMA
PET CT-RECTUM studie kort
PET CT-RECTUM studie lang
PLEM
PRE DETECT-HF
Prep4Heat
PRIMI
ProVag
STAR
STRONG II
Thunder
TUMAGNOSTIC
Youth-GEMs
AEO
| Name | Indoor air quality, temperature and cognitive performance study |
| Acronym | Aeolus |
| Type | ☒ Other: Intervention |
| Diseases studied | Healthy |
| Description | Participant are exposed to 4 conditions with a different temperature and ventilation combination. The 4 conditions are High Temp & High Vent (HTHV), High Temp & Low Vent (HTLV), Low Temp & High Vent (LTHV), and Low Temp & Low Vent (LTLV). The High Temp is 35C, the Low Temp is 23C both with 40% relative humidity. On each test day participants are exposed for 8 hours. Blood and saliva are taken 4 times a day. Also measured are skin temperature, core temperature, metabolic rates, breathing rates, heart rates, blood pressure and sweat weight. Moreover, participants will complete 2 cognitive tests and 2 stepping tasks once in the morning and once in the afternoon. |
| Material collected | ☒ Plasma ☒ Saliva ☒ Serum ☒ Whole Blood |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to 40 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 22 |
| Registration number | 504 |
Archipelago
| Name | Archipelago |
| Acronym | Ovarian tumor |
| Type | ☒ Disease specific ☒ Hospital ☒ Rare Disease |
| Diseases studied | 2C73 Malignant neoplasms of ovary 2C74 Malignant neoplasms of fallopian tube 2F76 Neoplasms of uncertain behaviour of female genital organs 2F32 Benign neoplasm of ovary |
| Description | https://www.aocr.nl/ Archipelago of Ovarian Cancer Research (AOCR) is a nationwide platform for scientific research on ovarian cancer. |
| Material collected | ☒ Plasma ☒ Tissue, cryo preserved ☒ Tissue, paraffin preserved |
| Sex | ☒ Female |
| Age low – high | From: 18 to 100 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | Nationwide 1000 patients |
| Registration number | 482 |
ATHEROMAAS
| Name | Carotid Atherosclerosis cohort Maastricht |
| Acronym | ATHEROMAAS |
| Type | ☒ Cohort ☒ Longitudinal ☒ Population-based |
| Diseases studied | Atherosclerosis |
| Co-morbidities, eg. Chronic kidney disease, diabetes | |
| Description | The AtheroMAAS study aims to investigate the underlying mechanisms of and risk factors for the development and progression of atherosclerosis, the main underlying cause of cardiovascular diseases. For this biobank, we collect not only atherosclerotic plaques from patients that undergo carotid endarterectomy, but also plasma and Peripheral Blood Mononuclear Cells (PBMCs) for analyses. From these patients, we also collect clinical information to study the impact of risk factors on disease progression, with a particular focus on patients with chronic kidney disease or diabetes. |
| Material collected | ☒ Peripheral blood cells ☒ Plasma ☒ Tissue, cryo preserved ☒ Tissue, paraffin preserved |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: >18 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | Approximately 50/year |
| Registration number | 535 |
BIOBANK HUNTINGTON
| Name | Biobank Huntington MUMC+ |
| Acronym | BB-HD |
| Type | ☒ Case-Control ☒ Cohort ☒ Disease specific ☒ Longitudinal ☒ Rare Disease |
| Diseases studied | Huntington’s Disease, 8A01.10 |
| Description | The Huntington’s Disease (HD) Biobank enables future research into the early detection, progression, diagnosis, and treatment of Huntington’s disease, a severe neurodegenerative disorder caused by an expanded CAG repeat in the Huntington gene. HD is characterized by involuntary movements, cognitive decline, and neuropsychiatric symptoms. There is currently no cure, and treatments focus solely on symptom relief. By collecting biosamples and associated medical data, the biobank promotes future research towards a better understanding of the origin and progression of HD. Additionally, the biobank can be used to conduct research towards new treatments, aiding the development of potential disease-modifying interventions. This way, the biobank contributes to improving knowledge and care regarding HD. |
| Material collected | ☒ DNA ☒ Peripheral blood cells ☒ Plasma ☒ Saliva ☒ Serum ☒ Whole Blood ☒ Other: tear fluid and liquor |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 12 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | Ongoing |
| Registration number | 495 |
BRIMM-HUM
| Name | The effect of the indoor environmental quality on cognition and health |
| Acronym | HUM Study |
| Type | ☒ Other: Randomized |
| Diseases studied | Healthy |
| Description | To examine the effect of varying temperature and humidity combination on physiological parameters and cognition. The 4 conditions are 25C and 30% RH, 25C and 70% RH, 32C and 30% RH and lastly 32C and 70%RH. Participants are exposed for 8 hours in a day. Demographics taken include, age, weight, height, body fat %, VO2 submax, BMR, and estimated BSA. Primary measures are cognitive test scores, salivary cortisol level, metabolic rates, heart rate, skin temperature, core temperature, peripheral flows, sweat rate, and blood pressure. Salivary samples and blood pressure are every hour, metabolic rates and heart rates are continous. Cognitive tests are performed twice in a session once in the morning and once in the afternoon. |
| Material collected | ☒ Saliva |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 20 to 40 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 26 |
| Registration number | 474 |
Cardiale Amyloidose
| Name | Amyloid patients |
| Acronym | AMYLOID |
| Type | ☒ Cohort ☒ Longitudinal |
| Diseases studied | Cardiac amyloidosis |
| Description | A single center longitudinal cohort of patients with cardiac amyloidosis. Mostly transthyretin amyloidosis. |
| Material collected | ☒ Serum |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 50 to: 85 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 50 |
| Registration number | 497 |
Chloroquine GBM
| Name | A phase I trial for the addition of chloroquine, an autophagy inhibitor, to concurrent chemoradiation for newly diagnosed glioblastoma |
| Acronym | Chloroquine GBM |
| Type | ☒ Cohort ☒ Disease specific ☒ Population-based |
| Diseases studied | Grade IV supratentiorial astrocytoma (glioblastoma multiforme) |
| Description | Patients received radiotherapy and chemotherapy according to standard protocol (33 x 1.8 Gy in combination with TMZ 75mg/m2 po qd and 6 adjuvant cycles TMZ 150-200 mg/m2 po qd). Daily intake of chloroquine started one week before RT and ended at end RT. This phase I trial used a classical 3+3 design with escalating doses chloroquine (200 – 400 – 600 mg). Primary objective: : to determine the MTD/RPTD for CQ in combination with concurrent radiotherapy with daily TMZ in patients with a newly diagnosed GBM. Data collection: * Clinical examination (blood pressure, heart rate, Karnofsky performance status, weight, length) * Histopathological examination * Blood work: haemoglobin, white blood cell count, white blood cell differentiation, platelet count, serum creatinine, blood urea, liver function (bilirubin, LDH, gamma-GT, ALAT, ASAT, Alkaline Phosphatase), ions (Na, K, Cl, Ca, Mg), TSH. * Pharmacokinetic sampling * Autophagic marker LC3b * ECG * Tone audiogram (high-frequency tone-audiogram) * Ophthalmologic examination |
| Material collected | ☒ Peripheral blood cells ☒ Plasma ☒ Serum ☒ Tissue, cryo preserved ☒ Tissue, paraffin preserved ☒ Whole Blood |
| Sex | ☒ Undifferentiated |
| Age low – high | From: 18 to 70 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 13 |
| Registration number | 287 |
CVRM na PE
| Name | Structured cardiovascular risk management in women with a history of preeclampsia |
| Acronym | CVRM after preeclampsia |
| Type | ☒ Cohort ☒ Longitudinal ☒ Other: Health care evaluation |
| Diseases studied | Preeclampsia; Hypertensive Disorders of Pregnancy |
| Description | As part of standard care, the Transmural Women’s Day Center offers repeated cardiovascular risk evaluations to women who have experienced preeclampsia, focusing on both somatic and cognitive/psychological health sequalae. Former preeclamptic women are eligible for this health care program from as early as 6 months post-pregnancy up to decades thereafter. The offered risk evaluation includes laboratory analyses of venous blood and 24-hour urine, medical history taking, physical examination, 30-minutes blood pressure measurement, echocardiography, electrocardiogram, vascular function measurement, and questionnaires. Additional blood and urine samples are collected and stored at Biobank Maastricht from those who provide informed consent for this. |
| Material collected | ☒ DNA ☒ Plasma ☒ Serum ☒ Urine ☒ Whole Blood |
| Sex | ☒ Female |
| Age low – high | From: 25 to 65 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | Consecutive through health care. |
| Registration number | 513 |
ELDAPT
| Name | Elderly with locally advanced lung cancer: deciding through geriatric assessment on the optimal treatment strategy |
| Acronym | ELDAPT |
| Type | ☒ Disease specific |
| Diseases studied | stage III non-small cell lung cancer (NSCLC) |
| Description | A prospective multicenter observational study. All registered patients will undergo a geriatric assessment to assess vulnerability. Based on this assessment, patients are offered treatment according to the discretion of the physician and patient. Primary outcome: To corellate results of the geriatric assessment with quality-adjusted survival (QAS) after radical intent therapy in patients with stage III NSCLC ≥75 years. Two samples of saliva will be retained and stored for future exploratory biomarker studies. The predictive value of variations in mitochondrial DNA (mtDNA) will be assessed in the saliva samples. |
| Material collected | ☒ Saliva |
| Sex | ☒ Female ☒ Male ☒ Undifferentiated |
| Age low – high | From: 75 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 120 |
| Registration number | 274 |
EMPA-MVD
| Name | SGLT2 inhibitors and microvascular dysfunction |
| Acronym | EMPA-MVD |
| Type | ☒ Cohort ☒ Longitudinal ☒ Other: RCT |
| Diseases studied | Heart failure with preserved ejection fraction |
| Description | A single-centre prospective pre-post intervention study in patients with heart failure and preserved ejection fraction. Treatment with Empagliflozin will be initiated. Baseline and three months blood samples will be collected. |
| Material collected | ☒ Serum |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 50 to 85 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 50 |
| Registration number | 464 |
Endoscope CRC Cohort
| Name | Development and evaluation of diagnostic and prognostic biomarker profiles for ColoRectal Cancer and premalignant lesions |
| Acronym | Endoscope CRC cohort |
| Type | ☒ Cohort ☒ Cross-sectional ☒ Disease specific ☒ Hospital ☒ Population-based ☒ Other: cross-sectional with follow-up |
| Diseases studied | Malignant neoplasm of colon C18 Malignant neoplasm of rectosigmoid junction C19 Malignant neoplasm of rectum C20 Benign neoplasm of colon, rectum D12.0 – 12.8 |
| Description | The primary objectives of this study are: to identify and validate non-invasive biomarkers for pre-malignant and malignant colonic lesions, which can be used to aid CRC screening and improve polyp surveillance, with maximum true-negative rates, but low false-positive rates, with colonoscopy plus pathological evaluation as gold standard reference. The secondary, the obtained data will be the basis of the formation of a colorectal polyp and CRC-cohort and biobank (‘Endoscope-CRC biobank’). To set up a cohort and biobank of well-characterized patients for future translational studies on the pathophysiology and disease characteristics of premalignant and malignant colorectal lesions. The biobank includes blood plasma, DNA, faecal and breath samples, and permission will be asked to use histological material if obtained during endoscopy or surgery. |
| Material collected | ☒ Faeces ☒ Whole Blood |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 55 to 75 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 2000 |
| Registration number | 437 |
EORTC Prostaat
| Name | Ann Claessens |
| Acronym | EORTC Prostaat |
| Type | ☒ Disease specific |
| Diseases studied | Malignant neoplasm of rectum (C20) |
| Description | Post-operative external radiotherapy combined with concomitant and adjuvant hormonal treatment versus post-operative external radiotherapy alone in pathological stage pT3a-b R0-1 N0M0 / pT2 R1 N0M0, Gleason score 5-10 prostatic carcinoma. A Phase III study. Translational research Proteomics translational research: The primary objective of this research is to assess the value of human sera proteomic patterns for predicting the clinical course of patients randomized in the two arms. |
| Material collected | ☒ Plasma ☒ Whole Blood |
| Sex | ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 1 |
| Registration number | 109 |
Eye Tissue Bank Maastricht
| Name | Eye Tissue Bank Maastricht |
| Acronym | ETBM |
| Type | ☒ Cross-sectional ☒ Disease specific ☒ Hospital ☒ Rare Disease |
| Diseases studied | H10-H13 Disorders of conjunctiva H15-H22 Disorders of sclera, cornea, iris and ciliary body H25-H28: Disorders of lens H30-H36: Disorders of choroid and retina H40-H42 Glaucoma H43-H45: Disorders of vitreous body and globe |
| Description | The Eye Tissue Bank Maastricht stores clinical data and biomaterial (blood, tears and tissue released or removed during eye operations) of > 4000 patients. This material is used to study pathogenesis, to find biomarkers and to develop new treatments. |
| Material collected | ☒ DNA ☒ Plasma ☒ RNA ☒ Serum ☒ Tissue, cryo preserved ☒ Other: tears |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 0 to 100 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | >4000 |
| Registration number | 300, 413, 500, 511 |
FORCE-NEN
| Name | InFrastructure fOr Rare Cancers in the nEtherlands – NeuroEndocrine Neoplasms Multicenter Clinical Biobank |
| Acronym | FORCE-NEN |
| Type | ☒ Cohort ☒ Disease specific ☒ Longitudinal ☒ Rare Disease |
| Diseases studied | D3A/C7A – neuroendocrine neoplasms |
| Description | FORCE-NEN is a collaboration between the Dutch NEN expert centers in a multicenter clinical biobank aimed to create and maintain a comprehensive collection of clinicopathological data, imaging data and large-scale biobanking of donors with Neuroendocrine Neoplasms. Patients with a confirmed diagnosis of Neuroendocrine Neoplasm, ≥18 years or older and treated at one of the participating centres are eligible. From included patients clinical and imaging data will be collected for the biobank. For the majority of the donors blood (50ml) for the biobank will be collected at three timepoints: baseline, first evaluation and progression. For a subgroup (n=150) blood draws will be more frequent, at baseline, every evaluation after baseline with staging imaging and once between baseline and the first evaluation and once between first and second evaluation. |
| Material collected | ☒ Plasma ☒ Other: buffy coat |
| Sex | ☒ Female ☒ Male ☒ Not available |
| Age low – high | From: 18 to 99 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 45 |
| Registration number | 473 |
Frailty in Uremia
| Name | Frailty in Uremia: A survey on the effects of CKD 3-5 on physical functioning and – activity, quality of life and nutritional state. |
| Acronym | Frailty in Uremia |
| Type | ☒ Cohort ☒ Longitudinal |
| Diseases studied | Chronic kidney disease |
| Description | The number of patients with chronic kidney disease and end-stage renal disease is increasing rapidly. Chronic kidney disease has besides cardiovascular and metabolic complication also an effect on physical functioning, -activity and quality of life. Our primary objective is to assess the longitudinal effects of differences and changes in renal function at CKD stage 3-5 on physical functioning. The secondary objectives is to look at the differences and changes at CKD stage 3-5 on physical activity, nutritional status, cardiovasculair function, quality of life, symptom burden, illness perception, anxiety and depression. The third objective is to assess the relation between different methods used to assess body composition with muscle strength hand physical activity. We will include 131 patients with CKD stage 3-5 and 65 healthy controls where we will measure a selection of non-invasive techniques and laboratory parameters at inclusion and annually during follow up of four years. |
| Material collected | ☒ Plasma ☒ Serum ☒ Urine |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: >18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 196 |
| Registration number | 459 |
HealthySauna
| Name | Healthy Sauna |
| Acronym | HealthySauna |
| Type | ☒ Longitudinal ☒ Population-based ☒ Other: Single arm experimental trial |
| Diseases studied | N/A |
| Description | The rising prevalence of overweight and obesity, along with its associated comorbidities, represents a significant health concern that remains insufficiently addressed by current therapeutic options. An emerging alternative is the use of thermal interventions to enhance metabolic health. Sauna therapy present a generally well-tolerated and accessible treatment option combining both heat and cold, both of which have been shown to beneficially influence cardiometabolic health. This study will assess whether repeated exposure to infrared sauna followed by cold-water immersion improves glucose homeostasis in healthy overweight adults, a population at heightened risk for cardiovascular and metabolic disorders. Besides glucose homeostasis, thermophysiological, cardiovascular and metabolic measures, inflammatory markers, functional outcomes, muscle morphology, subjective perception and mental well-being will be assessed. |
| Material collected | ☒ Plasma ☒ Serum |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 40 to 75 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 16 |
| Registration number | 532 |
HN Tumor Biobank
| Name | Head and Neck Tumor Biobank |
| Acronym | HN Tumor Biobank |
| Type | ☒ Disease specific |
| Diseases studied | (suspected) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx or oral cavity |
| Description | In HNSCC patients, advances in molecular biology with the development of genomic and proteomic approaches have also demonstrated distinct prognostic patient subsets, beyond those defined by traditional clinical-pathological factors such as tumor subsite and stage. Predictive models are needed to deal with multiple predictive factors and that the inclusion of gene-signature data and/or other molecular biomarkers from fresh-frozen tumor tissue will improve outcome prediction. However, validation of these biomarkers and other emerging prognostic factors in large prospective cohort studies is required before these markers can be introduced as standard clinical practice. Collect primary tumor biopsy material for storage in a HN Tumor Biobank from all patients with Head and Neck Squamous Cell Carcinoma (HNSCC). These biopsies will be stored fresh-frozen until further analysis. |
| Material collected | ☒ Tissue, cryo preserved |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 352 |
| Registration number | 150 |
IPON-1
| Name | Immune profiling of stage III non-small cell lung cancer patients treated with concurrent chemoradiation and adjuvant durvalumab: A prospective observational phase II trial |
| Acronym | IPON-1 |
| Type | ☒ Disease specific ☒ Longitudinal |
| Diseases studied | Lung cancer |
| Description | To identify immune changes in stage III NSCLC patients receiving concurrent chemoradiation with protons or photons followed by durvalumab. |
| Material collected | ☒ Plasma ☒ Serum ☒ Whole Blood ☒ Other: PBMC |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 45 |
| Registration number | 420 |
L19-IL2
| Name | Phase I clinical study combining L19-IL2 with stereotactic ablative body radiotherapy in patients with oligometastatic solid tumor. |
| Acronym | L19-IL2 |
| Type | ☒ Cohort ☒ Disease specific ☒ Longitudinal |
| Diseases studied | Oligometastatic solid tumor |
| Description | To determine the safety and efficacy of L19-IL2 combined with SABR in patients with an oligometastatic solid tumor (non-small cell lung cancer; NSCLC, head and neck squamous cell carcinoma; HNSCC, colorectal cancer; CRC, renal cell carcinoma; RCC, melanoma) |
| Material collected | ☒ cDNA / mRNA ☒ DNA ☒ Plasma ☒ Serum ☒ Whole Blood |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 8 |
| Registration number | 286 |
NVALT28
| Name | NVALT28/ PRL01 Durvalumab and low-dose Prophylactic Cranial Irradiation (PCI) versus durvalumab and observation in radically treated patients with stage III nonsmall cell lung cancer: A phase III randomized study |
| Acronym | NVALT28 |
| Type | ☒ Disease specific ☒ Longitudinal ☒ Rare Disease |
| Diseases studied | Lung cancer |
| Description | To evaluate whether the addition of low dose PCI to durvalumab after concurrent chemo-radiotherapy for stage III NSCLC reduces the cumulative incidence of brain metastases |
| Material collected | ☒ Plasma ☒ Other: Buffycoat |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 22 |
| Registration number | 442 |
OPTIMA
| Name | Evaluation of potential biomarkers during irinotecan-based systemic treatment for colorectal cancer |
| Acronym | OPTIMA Study |
| Type | ☒ Cohort ☒ Disease specific ☒ Hospital ☒ Longitudinal |
| Diseases studied | Advanced Colorectal Cancer |
| Description | Background |
| Patients with advanced colorectal cancer (CRC) commonly receive irinotecan-based systemic treatment to alleviate symptoms, improve quality of life (QoL), and prolong overall survival (OS). However, predicting efficacy and toxicity of the treatment is challenging. Previous research indicated an association between the tumor molecular profile and response to irinotecan-based systemic treatment. Moreover, the UGT1A1 genotype of the patient, and the activity of the gut microbial enzyme β-glucuronidase (GUS) have been suggested as biomarkers for the development of systemic (e.g. neutropenia) and gastrointestinal toxicity (e.g. diarrhea) respectively. Therefore, the OPTIMA study will evaluate in patients with advanced CRC: 1. whether tumor molecular profiling can predict the efficacy of irinotecan-based systemic treatment; 2. whether high bacterial GUS enzyme activity is associated with increased gastrointestinal toxicity, decreased QoL and OS; as well as 3. the safety of a 70% irinotecan dose intensity in UGT1A1 poor metabolizers (PMs). |
|
| Methods | |
| This prospective, observational, multi-center cohort study will include patients with advanced CRC scheduled for irinotecan-based systemic treatment. Archived tumor tissue and routine CT/MRI scans at baseline and after four cycles will be used to investigate the association of tumor molecular profile and treatment response according to RECIST. Before treatment initiation, germline DNA obtained from whole blood will be genotyped using PCR to determine the UGT1A1*28 genotype, followed by 30% irinotecan dose reduction in UGT1A1 PMs. Bacterial GUS activity will be quantified in fecal samples collected before and during treatment by means of an enzyme activity assay and will be related to patient-reported gastrointestinal toxicity (mainly diarrhea). Additionally, patients will fill in questionnaires concerning QoL, medication use, medical history and comorbidities, dietary habits, as well as physical performance. OS will be documented, capturing the duration from the start of treatment until death from any cause. |
|
| Discussion | |
| Results obtained in the context of the OPTIMA study are expected to contribute to the optimization of efficacy and the reduction of toxicity of irinotecan-based systemic treatment, thereby potentially improving QoL of patients. Given that maintaining QoL is particularly critical in the palliative setting, the OPTIMA study has the potential to be of significant benefit for patients and their caregivers. |
|
| Material collected | ☒ Faeces ☒ Tissue, paraffin preserved ☒ Whole Blood |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 104 |
| Registration number | 545 |
PET-CT-RECTUM STUDIE KORT
| Name | PET-CT-RECTUM STUDIE KORT |
| Acronym | PET-CT-RECTUM STUDIE KORT |
| Type | ☒ Disease specific |
| Diseases studied | Malignant neoplasm of rectum (C20) |
| Description | To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy. Study hypothesis: The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response. Changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during treatment will be studied in 40 evaluable patients with rectal cancer receiving radiotherapy alone Endpoints : Prediction of the pathological tumor response shortly after radiotherapy by a PET-CT scan and blood samples for the patients receiving short-course radiotherapy alone |
| Material collected | ☒ Plasma ☒ Serum ☒ Whole Blood |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 53 |
| Registration number | 029-K |
PET-CT-RECTUM STUDIE LANG
| Name | PET-CT-RECTUM STUDIE LANG |
| Acronym | PET-CT-RECTUM STUDIE LANG |
| Type | ☒ Disease specific |
| Diseases studied | Malignant neoplasm of rectum (C20) |
| Description | Aim of the trial : To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy. Study hypothesis: The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response. Changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during treatment will be studied in 60 evaluable patients with rectal cancer receiving concurrent chemotherapy and adiotherapy. Endpoints : Prediction of the pathological tumour response 6-8 weeks after radio chemotherapy treatment by PET-CT scans and by blood samples on days 7 and 14 during concurrent radiotherapy and chemotherapy. |
| Material collected | ☒ Plasma ☒ Serum ☒ Whole Blood |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 122 |
| Registration number | 029-L |
PLEM
| Name | Poli Late Effen Mamma |
| Acronym | PLEM |
| Type | ☒ Cross-sectional ☒ Disease specific |
| Diseases studied | Late patient outcomes of patients treated in Maastro Clinic in the year 2002-2003 for breast carcinoma with curative intent. |
| Description | Intervention: Questionnaires, one visit to Maastro Clinic in 2013/2014, physical examination, cosmetic photograph of the breast and an optional venipuncture, saliva is collected (optional) |
| Material collected | ☒ Plasma ☒ Saliva ☒ Serum ☒ Whole Blood |
| Sex | ☒ Female |
| Age low – high | From: 42 to 89 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 136 |
| Registration number | 200 |
Pre-DETECT HF
| Name | Pre-Symptomatic Detection of Impending Decompensation in Heart Failure through Voice Data (PRE-DETECT-HF) |
| Acronym | Pre-DETECT HF |
| Type | ☒ Cohort ☒ Longitudinal |
| Diseases studied | Heart failure |
| Description | I50 Heart failure |
| Material collected | ☒ Plasma |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: >18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 120 |
| Registration number | 526 |
Prep4Heat
| Name | Preparing for heat waves |
| Acronym | Prep4heat |
| Type | ☒ Other: Non-randomized experimental trial |
| Diseases studied | Thermoregulation |
| Description | As the ongoing progression of global warming exposes individuals to extreme heat, there is increasing scientific interest to prevent medical emergencies caused during heat waves. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. The study aims to assess the effect of passive heat acclimation, in combination with low-to-moderate intensity exercise, on cardiovascular, thermophysiological and metabolic responses in overweight, older individuals. |
| Material collected | ☒ Plasma ☒ Serum |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 60 to 80 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 12 |
| Registration number | 505 |
PRIMI
| Name | Preterm Immune system development and response to Immunization |
| Acronym | PRIMI study |
| Type | ☒ Cohort ☒ Longitudinal |
| Diseases studied | Immune system development of preterm born infants (born before 32 weeks GA) |
| Description | The primary objective is to study the antibody immune response to routine vaccinations in very preterm infants. (born before 32 weeks GA) The secondary aim is to study the immune system more extensively using flow cytometry, ELISA and single cell transcriptomics to measure development of antigen (Ag)-specific memory B cells raised in response to vaccination, and by using proteomics, epigenetics, and microbiome studies. |
| Material collected | ☒ Faeces ☒ Peripheral blood cells ☒ Plasma ☒ Serum |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 0 to 12 |
| Unit | ☐ Days ☐ Weeks ☒ Months ☐ Years |
| Number of donors | 120 preterm infants, 120 mothers of preterm infants, 25 controls (infants born > 37 weeks GA) |
| Registration number | 463 |
ProVag
| Name | ProVag – The effect of oral probiotics intake on the vaginal microbiota composition |
| Acronym | ProVag |
| Type | ☒ Other: Randomized controlled Trial |
| Diseases studied | Infertility |
| Description | Randomized, placebo-controlled double-blind intervention that aims to elucidate whether oral probiotic treatment changes the vaginal microbiome profile of IVF patients from a low to a medium/high score (based on the receptIVFity test) compared to placebo treatment. Participants (n=110) with a low receptIVFity profile will receive probiotic or placebo treatment for 8 weeks. |
| Material collected | ☒ Other: Vaginal and rectal swabs |
| Sex | ☒ Female |
| Age low – high | From: 18 to 43 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 110 |
| Registration number | 509 |
STAR
| Name | STudying Ageing in Rheumatoid arthritis (STAR) stored serum |
| Acronym | STAR stored serum |
| Type | ☒ Case-Control ☒ Cross-sectional |
| Diseases studied | ICD-10 M06.9 Rheumatoid arthritis |
| Description | The goal of the STudying Ageing in Rheumatoid arthritis (STAR) study is to gain insight into the effect of ageing on the result of disease activity measures, decline in cognition, physical activity and performance. In total, 420 patients with RA will be compared to 420 population controls between 55 and 85 years of age. In 180 participants (90 patients with RA and 90 population controls) one blood sample will be collected for the determination of CRP and ESR values, and serum will be stored for potential future analyses. |
| Material collected | ☒ Serum |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 55 to 85 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 180 |
| Registration number | 486 |
STRONG II
| Name | Stereotactic body radiation therapy after chemotherapy for unresectable perihilar cholangiocarcinoma: a multicenter phase II trial |
| Acronym | STRONG II |
| Type | ☒ Cohort ☒ Disease specific ☒ Hospital ☒ Longitudinal |
| Diseases studied | unresectable perihilar cholangiocarcinoma (XH43E4) |
| Description | For patients with perihilar cholangiocarcinoma (pCCA), surgery is the only treatment modality that can result in cure. Unfortunately, most patients have unresectable tumors at presentation. The standard treatment for patients with unresectable pCCA is palliative chemotherapy (cisplatin and gemcitabine) which yields an estimated median overall survival (OS) of 12 months. In 2020 we completed a feasibility and phase I trial (STRONG 1) in six patients with stereotactic body radiation therapy (SBRT), delivered after chemotherapy to test its tolerability in patients with unresectable pCCA. We observed no dose-limiting toxicity (DLT), defined as grade ≥ 4 hepatobiliary or grade ≥ 3 gastrointestinal toxicity. The 12-month local tumor control rate was 80%, median survival was not reached, and there were no substantial changes in quality of life (QoL). The objective of the study is to confirm the efficacy of SBRT in a larger cohort of patients regarding local tumor control, toxicity, progression-free survival (PFS), OS, and QoL. Additionally, this study will include a translational part to explore the value of peripheral immunodynamics in predicting survival. |
| Material collected | ☒ Serum |
| Sex | ☒ Unknown |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 4 |
| Registration number | 515 |
Thunder
| Name | Thunder |
| Acronym | Thunder |
| Type | ☒ Disease specific |
| Diseases studied | Malignant neoplasm of rectum (C20) |
| Description | Prospective validation of a predictive model for pathologic complete response after chemoradiotherapy in rectal cancer: A prognostic study. Objective: The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient. |
| Material collected | ☒ Plasma ☒ Serum ☒ Whole Blood |
| Sex | ☒ Male ☒ Female |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 91 |
| Registration number | 096 |
TUMAGNOSTIC
| Name | TUMAGNOSTIC |
| Acronym | TUMAGNOSTIC |
| Type | ☒ Cohort ☒ Longitudinal |
| Diseases studied | C-00-C97 Malignant neoplasms |
| Description | A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic Hypoxia Activated Prodrug in patients with HRD/FAD solid tumors or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumor and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial. We will evaluate blood-based hypoxia biomarkers at the same time points as imaging. We will investigate the potential of hypoxia-induced genes in blood liquid biopsies (cfDNA and circulating tumor cells) to predict the degree of tumor hypoxia and its change during treatment. |
| Material collected | ☒ Peripheral blood cells ☒ Plasma |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 18 to … |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | 126 |
| Registration number | CP-506 |
Youth GEMs
| Name | Youth-GEMs |
| Acronym | Youth-GEMs |
| Type | ☒ Population-based |
| Diseases studied | (Risk of developing) Psychiatric Disorders |
| Description | These participants (age 12-24) are recruited after their first encounter with mental health services. They experience problems with mental health but are not necessarily diagnosed (yet). Data on demographics are available as well as clinical data and questionnaires. FU questionnaire data are possibly collected at 3, 6, 12, 18 and 24 months. Available biological samples include DNA and plasma. (Samples will be available in 2027.) To be able to work with the data, a publication proposal should be sent to the vice coordinator of Youth-GEMs: Sinan Gülöksüz |
| Material collected | ☒ DNA ☒ Plasma |
| Sex | ☒ Female ☒ Male |
| Age low – high | From: 12 to 24 |
| Unit | ☐ Days ☐ Weeks ☐ Months ☒ Years |
| Number of donors | Anticipated: ~800 – 1000 samples |
| Registration number | 519 |