Using blood tests to manage gastrointestinal tumors
Prospective Single-center Study About the Use of Ctdna in the Management of Patients With Tumors of the Gastrointestinal Tract
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06202131
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06202131 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a histological diagnosis of gastrointestinal cancer and evidence of resectable, locally advanced, or metastatic disease.
Not a fit: Patients without a histological diagnosis of gastrointestinal neoplasia or those unable to provide informed consent may not benefit from this study.
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 performed: Other studies have shown promise in using ctDNA for cancer management, indicating a growing interest and potential in this area.
Eligibility criteria
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 this trial is running
Rome, Lazio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreas Cancer, Colon Cancer, Biliary Tract Cancer