The Future Management Of Patients With Neoplasms Of The Gastro-intestinal Tract

Study Overview

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

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

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

Pancreatic Adenocarcinoma
Cholangiocarcinoma
Colon Cancer

DIAGNOSTIC_TEST: Molecular analyses

6723

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-12-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-10
First Submitted that Met QC Criteria 2024-12-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-11
First Posted (ACTUAL) 2024-12-11	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Patients undergoing molecular analysis Patients undergoing molecular analysis	DIAGNOSTIC_TEST: Molecular analyses Search for molecular alterations that correlate with patient prognosis

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Patients undergoing molecular analysis

Patients undergoing molecular analysis

DIAGNOSTIC_TEST: Molecular analyses

Search for molecular alterations that correlate with patient prognosis

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Lisa Salvatore, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record