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

Launched by UNIVERSITY HOSPITAL, ANTWERP · Aug 1, 2024

Keywords

ClinConnect Summary

The CollectNET 2.0 study is looking to gather blood samples, known as liquid biopsies, from patients diagnosed with neuroendocrine neoplasms (NEN). These samples will help create a large collection of biological materials that researchers can use to learn more about the disease and develop new testing methods. There are two groups in the study: one group will have regular blood samples taken, while another group will have more frequent samples if they are starting specific treatments. The goal is to analyze the DNA found in these samples to better understand how the cancer behaves and to see if this DNA can help predict how well patients are responding to their treatments.

To join the study, participants need to be 18 years or older and must have a confirmed diagnosis of NEN with measurable tumors. They should be receiving care at one of the participating hospitals. While taking part, participants can expect to have up to four blood tubes collected at various times as part of their treatment. This study is designed to provide valuable insights for future cancer care and research, and all samples will be stored for further analysis down the line.

Gender

ALL

Eligibility 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.