Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Using blood tests to manage gastrointestinal tumors

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

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06202131 · Data updated 2026-11-12

This study is testing if blood tests that look for tumor DNA can help doctors better manage patients with gastrointestinal tumors like pancreatic, colon, and biliary tract cancers.

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment100 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Rome, Lazio)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedNovember 1, 2028
Study endsNovember 1, 2028
Registry record updatedSeptember 2, 2025
Trial IDNCT06202131 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with a histological diagnosis of gastrointestinal cancer and evidence of resectable, locally advanced, or metastatic disease.

Probably not a fit

Patients without a histological diagnosis of gastrointestinal neoplasia or those unable to provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the role of circulating tumor DNA (ctDNA) in managing patients with gastrointestinal tumors, including pancreatic, colon, and biliary tract cancers. Conducted at a single center, it involves collecting blood and fecal samples from patients at specific time points to analyze ctDNA as a biomarker. The aim is to enhance diagnostic and therapeutic strategies for these cancers while ensuring patient anonymity and data protection.

Why it matters

Potential benefit: If successful, this approach could lead to improved management and treatment outcomes for patients with gastrointestinal tumors.

How similar studies have gone: Other studies have shown promise in using ctDNA for cancer management, indicating a growing interest and potential in this area.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Policlinico Agostino Gemelli
    Rome, Lazio, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.