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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00160, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Molecular analyses

Diagnostic Test

Search for molecular alterations that correlate with patient prognosis

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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: SOCRATE

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Dec 11, 2024
Registry last updated: Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed