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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06728358

Acronym

SOCRATE

Enrollment

300

Registered

2024-12-11

Start date

2024-12-01

Completion date

2028-12-01

Last updated

2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma, Colon Cancer, Pancreatic Adenocarcinoma

Keywords

Pancreatic cancer, Bile duct cancer, Colon cancer

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.

Interventions

DIAGNOSTIC_TESTMolecular analyses

Search for molecular alterations that correlate with patient prognosis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026