Actively Recruiting
Epigenomic Biomarkers for Noninvasive Diagnosis of Neuroendocrine and Mixed Neuroendocrine Tumors Using DNA Methylation-Based Liquid Biopsy Assay
Led by European Institute of Oncology · Updated on 2025-01-21
130
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
E
European Institute of Oncology
Lead Sponsor
A
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying mixed neuroendocrine and non-neuroendocrine tumors called GEP-MiNENs and neuroendocrine neoplasms (NENs), which can be challenging to diagnose early due to the small and deep location of neuroendocrine components. The goal is to improve diagnosis and monitoring by developing a non-invasive liquid biopsy test that detects specific DNA methylation patterns in circulating tumor DNA, offering advantages over traditional tissue biopsies. The study plans to create a DNA methylation-based assay using advanced sequencing technology from Oxford Nanopore Technologies to analyze both DNA sequences and methylation profiles simultaneously. This approach aims to identify tumor-specific epigenetic markers in blood samples, enabling accurate detection and monitoring of these rare and complex tumors. Researchers will compare these profiles with reference cell and tissue maps to improve the test's accuracy. Participants will be monitored over two years as researchers develop the assay, collecting blood samples to analyze circulating tumor DNA and its epigenetic features. The study will measure the ability of the test to detect and track neuroendocrine tumors non-invasively. This research hopes to provide a new tool for earlier diagnosis and better management of these cancers, improving patient care and treatment decisions.
CONDITIONS
Official Title
EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Neuroendocrine Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 including colorectal carcinoma, small intestine carcinoma, gastric or oesophageal carcinoma, pancreatic ductal adenocarcinoma, or metastasectomy from any non-NEN GI carcinoma
You will not qualify if you...
- Grading G1 and G2 with \u226410% Ki67
- Presence of concomitant neoplasm within 3 years
- Concomitant major haematological alteration
- Concomitant major organ dysfunction such as grade 3 or 4 liver or kidney failure
- Ongoing chemotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
N
Nicola Fazio, MD
F
Francesca Spada, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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