EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Neuroendocrine Neoplasms

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose and monitor certain types of tumors called mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs). These tumors can be tricky to identify because the neuroendocrine (NE) part is often found deep inside the body and may be small, making it hard to detect with standard biopsy methods. The researchers aim to develop a special blood test that looks for changes in DNA (called DNA methylation) in order to find traces of these tumors without needing a traditional tissue biopsy. This could improve how quickly and accurately doctors can diagnose these tumors and decide on the best treatment options.

To join the trial, participants must have a confirmed diagnosis of either a neuroendocrine carcinoma (NEC) or a MiNEN that is suitable for surgery. They may also have certain other types of cancers, like colorectal or pancreatic cancer, as long as they are not too advanced or have other serious health issues. During the study, participants can expect to provide blood samples and undergo regular monitoring to help the researchers understand how well the new blood test works. This trial is a step towards finding better, less invasive ways to diagnose and manage these complex tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with histologically confirmed diagnosis of NEC/MINEN amenable to surgery with radical intent
• • Patient with histologically confirmed diagnosis of NET amenable to surgery with radical intent
• • Patient with metastatic NET/NEC, amenable to biopsy or surgery, including palliative intent
• * Patient histologically confirmed non-NEN histotype:
• • 1. Colorectal carcinoma
• • 2. Small intestine carcinoma
• • 3. Gastric or oesophageal carcinoma
• • 4. Pancreatic ductal adenocarcinoma
• • 5. Metastasectomy from any non-NEN GI carcinoma
• Exclusion Criteria:
• • Grading G1 and G2 \<=10% Ki67
• • Presence of concomitant neoplasm (within 3 years)
• • Concomitant major haematological alteration
• • Concomitant major organ dysfunction (e.g. G3/4 liver or kidney failure)
• • Ongoing chemotherapy