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 type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | November 1, 2028 |
| Study ends | November 1, 2028 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT06202131 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
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Policlinico Agostino Gemelli
Rome, Lazio, Italy Recruiting
Study contacts
- Principal investigator: Lisa Sakvatore, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Lisa Salvatore, MD, PhD
- Email: lisa.salvatore@policlinicogemelli.it
- Phone: +390630156318
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.