Prospective Single-center Study About the Use of ctDNA in the Management of Patients With Tumors of the Gastrointestinal Tract

Recruiting

• Conditions: Pancreas Cancer; Biliary Tract Cancer; Colon Cancer

• Registration Number: NCT06202131
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

This study will evaluate the use of ctDNA in the clinical management of patients with tumors of the gastrointestinal tract.

Detailed Description

This is a a prospective observational single-center study; it is a spontaneous study, not sponsored by pharmaceutical companies, and does not involve the use of experimental drugs. The study involves a collection of data, carried out while protecting the anonymity and personal information of individual patients suffering from neoplasms of the gastrointestinal tract, the execution of peripheral blood samples and the collection of faecal material at pre-determined times -points. Circulating biomarkers (as ctDNA) will be evaluated in these samples, in order to optimize both the diagnostic and therapeutic processes of patients with tumors of the gastrointestinal tract.

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2023-12
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Primary Completion: 2028-11-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age >18 years
• PS ECOG <2;
• Histological diagnosis of gastrointestinal cancer: esophageal, gastric, intestinal, pancreatic, biliary tract neoplasms;
• Radiological evidence of resectable/locally advanced/metastatic disease on the date of signing the written informed consent;
• Adequate organ and function;
• Availability of tumor histological material.

Exclusion Criteria

• No histological diagnosis of neoplasia of the gastrointestinal tract.
• No written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mOS	3 years	The primary endpoint of the study is to evaluate the probability of overall survival (mOS) in relation to the expression of specific molecular markers present in the plasma/faeces of patients.

Trial Locations

Locations (1)

Policlinico Agostino Gemelli; 🇮🇹 Roma, Lazio, Italy