Actively Recruiting

Age: 18Years +
All Genders
NCT06785597

EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Neuroendocrine Neoplasms

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

For GEP mixed neuroendocrine (NE) non-neuroendocrine neoplasms (MiNENs) a key issue affecting prognosis is sometimes the difficulty in obtaining a timely diagnosis, as the NE component is often localized in deeper anatomical locations and/or becomes prevalent over time. The tissue material of biopsies may be not enough to define the NE component when this is particularly small and this could impact on therapeutic decision. Furthermore GEP NENs need to be characterized for potentially druggable biomarkers and liquid biopsy has clear advantage to the solid one to this aim. Here, we will exploit epigenetic differences characterizing NE tumors to build a DNA methylation-based liquid biopsy assay able to detect circulating tumor DNA of NE derivation, to enable the non-invasive diagnosis and monitoring of GEP-MiNENs.

CONDITIONS

Official Title

EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Neuroendocrine Neoplasms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

European Institute of Oncology

Milan, Italy, 20141

Actively Recruiting

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Research Team

N

Nicola Fazio, MD

CONTACT

F

Francesca Spada, MD

CONTACT

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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