Collection of blood samples from patients with neuroendocrine neoplasms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Antwerp University Hospital (UZA)
  Edegem, Belgium Recruiting
• 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

Study contacts

• Principal investigator: Timon Vandamme — University Hospital, Antwerp
• Study coordinator: Siddharth Chhajlani
• Email: siddharth.chhajlani@uantwerpen.be
• Phone: 03436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.