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

NCT06728358 | Active Not Recruiting

• 1 other identifier: 6723
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma; Cholangiocarcinoma; Colon Cancer

Keywords

Pancreatic cancer; Bile duct cancer; Colon cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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.

  48 months

Study Arms (1)

Patients undergoing molecular analysis

EXPERIMENTAL

Patients undergoing molecular analysis

Diagnostic Test: Molecular analyses

Interventions

Molecular analyses DIAGNOSTIC_TEST

Search for molecular alterations that correlate with patient prognosis

Patients undergoing molecular analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00160, Italy

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Colonic Neoplasms; Pancreatic Neoplasms; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Lisa Salvatore

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)