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NCT Number: NCT06202131

Use of Ctdna in Patients With Gastrointestinal Tract Tumors

This study will evaluate the use of ctDNA in the clinical management of patients with tumors of the gastrointestinal tract.

Recruiting

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Key information

Conditions

Pancreas Cancer Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms 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 Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is a a prospective observational single-center study; it is a spontaneous study, not sponsored by pharmaceutical companies, and does not involve the use of experimental drugs. The study involves a collection of data, carried out while protecting the anonymity and personal information of individual patients suffering from neoplasms of the gastrointestinal tract, the execution of peripheral blood samples and the collection of faecal material at pre-determined times -points. Circulating biomarkers (as ctDNA) will be evaluated in these samples, in order to optimize both the diagnostic and therapeutic processes of patients with tumors 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
  • PS ECOG <2;
  • Histological diagnosis of gastrointestinal cancer: esophageal, gastric, intestinal, pancreatic, biliary tract neoplasms;
  • Radiological evidence of resectable/locally advanced/metastatic disease on the date of signing the written informed consent;
  • Adequate organ and function;
  • Availability of tumor histological material.

Exclusion criteria

  • No histological diagnosis of neoplasia of the gastrointestinal tract.
  • No written informed consent.

Treatment and study plan

Primary outcomes

  1. mOS

    Time frame: 3 years

    The primary endpoint of the study is to evaluate the probability of overall survival (mOS) in relation to the expression of specific molecular markers present in the plasma/faeces of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Trovato, MD

CONTACT

[email protected]

+390630156318

Lisa Salvatore, MD, PhD

CONTACT

[email protected]

+390630156318

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Prospective Single-center Study About the Use of Ctdna in the Management of Patients With Tumors of the Gastrointestinal Tract

Acronym: ctdna-GI

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 11, 2024
Registry last updated
Sep 2, 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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