Single-centre Prospective Study on the Identification of Clinical, Laboratory, Anatomopathological and Molecular Characteristics for the Future Management of Patients With Neoplasms of the Gastro-intestinal Tract

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country300 target enrollmentDecember 1, 2024

ConditionsPancreatic Adenocarcinoma Cholangiocarcinoma Colon Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pancreatic Adenocarcinoma
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment: 300
Locations: 1
Primary Endpoint: Overall Survival
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2024

End Date

December 1, 2028

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Overall Survival

Time Frame: 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.