The Future Management of Patients With Neoplasms of the Gastro-intestinal Tract

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Adenocarcinoma; Cholangiocarcinoma; Colon Cancer

• Registration Number: NCT06728358
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The aim of the present study is to research histological and molecular markers in patients with neoplasia of the gastrointestinal tract.

Detailed Description

The aim of the present study is to search for histological and molecular markers in patients with neoplasia of the gastrointestinal tract.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2028-11-30
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age 18 years or older;
• PS ECOG 0-2;
• Histological diagnosis of cancer of the gastro-enteric district: intestinal, pancreatic, biliary tract neoplasms;
• Radiological evidence of resectable/locally advanced/metastatic disease on the date of the first visit;
• Availability of tumour histological material;
• At least one visit following the first oncological visit.

Exclusion Criteria

• Absence of histological diagnosis of neoplasm of the gastro-enteric tract;
• Lack of histological specimens on which to perform examinations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Survival	48 months	The primary objective of the study is to evaluate the probabilitỳ of survival in terms of OS in relation to the expression of specific anatomopathological, immunohistochemical and molecular markers (GATA6, GemPred Molecular Signature and FOLFIRINOX Molecular Signature) present in the tumour tissue of patients with neoplasms of the gastro-enteric district in the setting of resectable/metastatic disease.

Trial Locations

Locations (1)

Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Lazio, Italy