Collection of Liquid Biopsy Samples of Neuroendocrine Neoplasms (NEN) Patients - Collection of NET (CollectNET) 2.0, a Study by the BE-FORCE Consortium
NCT Number: NCT06541080
Acronym: BE-FORCE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neuroendocrine Neoplasms
Interventions: DIAGNOSTIC_TEST: Shallow Whole Genome Sequencing (sWGS)-GIPXplore|DIAGNOSTIC_TEST: methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assay
Sponsor: University Hospital, Antwerp
Collaborators: Universitaire Ziekenhuizen KU Leuven|Universiteit Antwerpen|KU Leuven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 550
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-03
Completion Date: 2030-12-04
Locations: AZ Rivierenland, Rumst, Antwerp, Belgium|VITAZ, Sint-Niklaas, East-Flanders, Belgium|University Hospital Leuven, Leuven, Flemish Brabant, Belgium|Ziekenhuis Netwerk Antwerpen (ZNA), Antwerpen, 2020, Belgium|Gasthuiszusters Ziekenhuizen (GZA), Antwerpen, 2610, Belgium|AZ Monica, Antwerpen, Belgium|AZ Klina, Brasschaat, 2930, Belgium|Antwerp University Hospital (UZA), Edegem, 2650, Belgium

Summary:
The CollectNET 2.0 by BE-FORCE is a prospective, multicentric, interventional study in which liquid biopsies will be collected from neuroendocrine neoplasms (NEN) patients to create an extensive biobank that will be used for current and future circulating cell-free DNA (ccfDNA) analyses. Two sampling groups will be created: the "Regular Sampling Group" and the "Intensive Sampling Group". Upon participation, up to four additional blood tubes (max. total of 32.5mL) will be collected at each timepoint as specified below. These include 3 Streck Cell-Free DNA tubes (10 mL each) which will be used for the extraction of ccfDNA and 1 PreAnalytiX (PAXgene)® Blood RNA tube (2.5 mL). All NEN patients in one of the participating hospitals who have measurable tumor burden on imaging will be asked to participate in our study and will be included in the "Regular Sampling Group". If additionally, the patient is (i) diagnosed with a histologically confirmed NEN of World Health Organisation (WHO) 2019 grade 1-3 neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC) from pancreatic, colorectal or small intestinal origin and (ii) is starting any kind of 1st line systemic treatment (e.g. somatostatin analogues, targeted therapy, chemotherapy, etc.), they will be followed up more intensively as per the "Intensive Sampling Group". If during follow-up in this "Intensive Sampling Group" patients have disease progression or have completed follow-up for 3 years in this group, their follow-up will switch back to the "Regular Sampling Group" for the remainder of the study. Ultimately, the samples collected in the "Intensive Sampling Group" will be used to achieve the second and third objective of our current project. These are to validate novel ccfDNA analyzing techniques (IMPRESS and GIPXplore) for assessment of the presence and quantification of circular tumor DNA (ctDNA) in liquid biopsies, and to monitor tumor fraction (i.e., ctDNA quantities) over time in sequential plasma samples from NEN patients using ccfDNA assays and correlating this with time to progression (according to RECIST 1.1 criteria) to explore the predictive efficacy of ccfDNA analysis and thereby evaluate its biomarker potential for patient follow-up. While samples from the "Regular Sampling Group" and the PAXgene tubes will be biobanked for future projects.

Primary Outcome Measures: Validating novel ccfDNA analyzing techniques for assessment of the presence and quantification of ctDNA in liquid biopsies derived from NEN patients, ctDNA fraction, 5 years after informed consent form (ICF) signature|Monitoring tumor fraction over time in sequential plasma samples from NEN patients using ccfDNA assays, ctDNA quantities, 5 years after ICF signature|Correlate tumor fraction with time to progression (according to RECIST 1.1 criteria), tumor fraction, 5 years after ICF signature