Collection of Liquid Biopsy Samples of Patients With Neuroendocrine Neoplasms - CollectNET 2.0, a Study by the BE-FORCE Consortium

What this Trial Is About

This research aims to collect liquid biopsy samples from patients with neuroendocrine neoplasms (NEN) to build a large biobank for analyzing circulating cell-free DNA (ccfDNA). The study focuses on validating new techniques to detect and measure circular tumor DNA (ctDNA) in blood samples and monitoring tumor DNA levels over time, linking these findings to disease progression. Patients included have measurable tumors, with a subgroup receiving more intensive monitoring if they start first-line systemic treatments for specific NEN types. Participants are divided into two groups: the Regular Sampling Group, including all NEN patients with measurable tumor burden, and the Intensive Sampling Group, which includes those starting first-line systemic treatments for pancreatic, colorectal, or small intestinal neuroendocrine tumors or carcinomas. Blood samples are collected at multiple timepoints, with up to four additional tubes taken each time for ccfDNA and RNA analysis. Patients in the Intensive Sampling Group switch back to Regular Sampling after progression or three years. During the study, participants provide periodic blood samples for ccfDNA and RNA extraction, with data collected over up to five years. Researchers assess new ccfDNA analysis methods and track tumor DNA levels using shallow whole genome sequencing and methylation-sensitive assays. They correlate tumor DNA quantities with disease progression based on imaging criteria. Samples from all participants are stored for future research. The study involves regular follow-up and monitoring of tumor burden and treatment response.

Collection of Liquid Biopsy Samples of Neuroendocrine Neoplasms (NEN) Patients - Collection of NET (CollectNET) 2.0, a Study by the BE-FORCE Consortium