Actively Recruiting
EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Noninvasive Diagnosis of Neuroendocrine Neoplasms
Led by European Institute of Oncology · Updated on 2025-01-21
130
Participants Needed
1
Research Sites
N/A
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 investigating gastroenteropancreatic (GEP) mixed neuroendocrine-non-neuroendocrine neoplasms (MiNENs), which are complex tumors with diagnostic challenges due to the neuroendocrine component often being small or located deep in the body. The study aims to develop a non-invasive diagnostic and monitoring tool by analyzing epigenetic differences, specifically DNA methylation, in circulating tumor DNA to detect neuroendocrine tumors. This approach could improve timely diagnosis and help understand tumor biology for better treatment strategies. The research involves developing a liquid biopsy assay using Oxford Nanopore Technologies sequencing, which can simultaneously analyze DNA sequence and methylation patterns. The study includes patients with confirmed neuroendocrine neoplasms and those with non-neuroendocrine gastrointestinal tumors as controls. The goal is to create a diagnostic test capable of detecting and monitoring these tumors through blood samples, overcoming limitations of traditional tissue biopsies. Participants will provide blood samples for analysis of circulating tumor DNA methylation and fragmentomics over a two-year period. Researchers will compare these molecular profiles to reference maps of normal and tumor tissue to identify specific biomarkers. The primary outcome is the successful development of this diagnostic assay, which could offer a less invasive option for diagnosis and ongoing monitoring of neuroendocrine tumors.
CONDITIONS
Brief 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 Ki67 less than or equal to 10%
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants provide samples for DNA methylation and fragmentomics analysis to develop a non-invasive liquid biopsy assay.
1 to 2 visits depending on cohort assignment
Duration - Up to 2 years
Participants are monitored over time to assess the performance of the diagnostic assay and disease status.
Periodic visits depending on clinical need
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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