Collection of blood samples from patients with neuroendocrine neoplasms
Collection of Liquid Biopsy Samples of Patients With Neuroendocrine Neoplasms - CollectNET 2.0, a Study by the BE-FORCE Consortium
This study is collecting blood samples from patients with neuroendocrine neoplasms to see if they can find new markers that help understand the disease better and improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Rumst, Antwerp and 7 other locations) |
| Trial ID | NCT06541080 on ClinicalTrials.gov |
What this trial studies
The CollectNET 2.0 initiative by the BE-FORCE Consortium aims to gather liquid biopsy samples from patients diagnosed with neuroendocrine neoplasms (NEN) to establish a comprehensive biobank. This observational study will categorize participants into two groups: a Regular Sampling Group and an Intensive Sampling Group, with blood samples collected at specified timepoints for analysis of circulating cell-free DNA (ccfDNA). The study will utilize advanced techniques such as shallow whole genome sequencing and methylation-sensitive assays to explore potential biomarkers for NEN. The goal is to enhance understanding of NEN and improve future diagnostic and therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histologically confirmed diagnosis of neuroendocrine neoplasms and measurable tumor burden.
Not a fit: Patients without a confirmed diagnosis of neuroendocrine neoplasms or those without measurable tumor burden may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and treatment strategies for patients with neuroendocrine neoplasms.
How similar studies have performed: Other studies utilizing liquid biopsies for cancer diagnostics have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female ≥ 18 years of age on the day of signing informed consent. * Written informed consent must be obtained from the patient or patient's legal representative. * Patient is willing and able (in the investigator's opinion) to comply with all trial requirements. * For inclusion in the Regular Sampling Group: patients must have (had) a histologically confirmed NEN diagnosis, patients must have measurable tumor burden on imaging, patients must be in follow-up in one of the participating hospitals and patients who have progressed or completed follow-up for 3y in the Intensive Sampling Group. * For inclusion in the Intensive Sampling Group: patients who are included in the Regular Sampling Group and where either a baseline sample (RSG-B) or a recent RSG follow-up sample (RSG-V…) has been collected before the start of 1st systemic treatment (as defined below), patients must be diagnosed with a histologically confirmed NEN diagnosis of a WHO 2019 grade 1-3 NET or NEC of pancreatic, colorectal, or small intestinal origin and patients must start any kind of 1st line systemic treatment (e.g. somatostatin analogues, targeted therapy, chemotherapy, etc.). Exclusion Criteria: * Patients who are unable to give informed consent. * Patients for which blood sampling would compromise their overall health. * Patients pregnant at time of study entry or are willing to become pregnant during the study. * Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
Where this trial is running
Rumst, Antwerp and 7 other locations
- AZ Rivierenland — Rumst, Antwerp, Belgium (Not_yet_recruiting)
- Vitaz — Sint-Niklaas, East-Flanders, Belgium (Not_yet_recruiting)
- University Hospital Leuven — Leuven, Flemish Brabant, Belgium (Not_yet_recruiting)
- Ziekenhuis Netwerk Antwerpen (ZNA) — Antwerp, Belgium (Not_yet_recruiting)
- Gasthuiszusters Ziekenhuizen (GZA) — Antwerp, Belgium (Not_yet_recruiting)
- AZ Monica — Antwerp, Belgium (Not_yet_recruiting)
- AZ Klina — Brasschaat, Belgium (Not_yet_recruiting)
- Antwerp University Hospital (UZA) — Edegem, Belgium (Recruiting)
Study contacts
- Principal investigator: Timon Vandamme — University Hospital, Antwerp
- Study coordinator: Siddharth Chhajlani
- Email: siddharth.chhajlani@uantwerpen.be
- Phone: 03436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.