Using advanced genetic testing to improve diagnosis of bile duct tumors
Official title: Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06729944 · Data updated 2026-11-12
This study is testing a new genetic test to see if it can help doctors better diagnose bile duct tumors in patients who are having surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | April 27, 2023 |
| Main results expected | May 2026 |
| Study ends | June 2026 |
| Registry record updated | December 12, 2024 |
| Trial ID | NCT06729944 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are undergoing biliary tract resection and have sufficient tissue available for analysis.
✕Probably not a fit
Patients who do not have sufficient tissue for analysis or are under 18 years old 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 study aims to enhance the diagnostic accuracy for biliary tract tumors by developing a specific next-generation sequencing (NGS) panel tailored for dysplasia and cholangiocarcinoma (CCA). Patients undergoing biliary tract resection will have their tissue samples analyzed to identify genetic markers that could improve sensitivity compared to traditional histological methods. The study will enroll 50 patients over a period of 36 months, collecting clinical and instrumental data to support the analysis. The samples will be processed at the Pathological Anatomy department of the IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of biliary tract tumors, potentially improving patient outcomes.
How similar studies have gone: While the use of next-generation sequencing in oncology is gaining traction, this specific application in biliary tract tumors is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Availability of enough tissue for histological and NGS analysis (at least 20 ng DNA). * Age greater than/equal to 18 years. Exclusion Criteria: * None
Where it's running
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Francesco Vasuri, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Francecso Vasuri, MD
- Email: francesco.vasuri2@unibo.it
- Phone: 0512143761
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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.