Using advanced genetic testing to improve diagnosis of bile duct tumors
Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06729944 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not have sufficient tissue for analysis or are under 18 years old may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna
- 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
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.