Identifying biomarkers for neuroendocrine tumors using liquid biopsies
EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Noninvasive Diagnosis of Neuroendocrine Neoplasms
This study is testing a new blood test to see if it can help doctors find and track mixed neuroendocrine tumors more easily.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT06785597 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a non-invasive liquid biopsy assay that detects circulating tumor DNA from neuroendocrine tumors, specifically focusing on mixed neuroendocrine and non-neuroendocrine neoplasms (MiNENs). By analyzing epigenetic differences, particularly DNA methylation patterns, the study seeks to improve the diagnosis and monitoring of these tumors, which often present diagnostic challenges due to their heterogeneous nature. The research utilizes advanced technologies like Oxford Nanopore Technologies to analyze both DNA sequence and methylation simultaneously, potentially paving the way for novel therapeutic approaches. The ultimate goal is to enhance patient outcomes through timely identification and monitoring of these complex tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed neuroendocrine tumors or mixed neoplasms that are amenable to surgical intervention.
Not a fit: Patients with low-grade tumors (G1 and G2 with Ki67 <= 10%) or those undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnoses of neuroendocrine tumors, improving treatment decisions and patient outcomes.
How similar studies have performed: Previous studies have shown promise in identifying epigenetic markers in tumor specimens, but this study's focus on liquid biopsies represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Nicola Fazio, MD — European Institute of Oncology
- Study coordinator: Nicola Fazio, MD
- Email: divisione.gastrointestinale@ieo.it
- Phone: 0257489258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.