Actively Recruiting
Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-12
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a specific next-generation sequencing (NGS) panel that targets dysplasia and cholangiocarcinoma (CCA) to improve the accuracy of diagnosing biliary tract narrowing. This exploratory study aims to enhance the sensitivity of histological and cytological exams for biliary tract stenosis. The study is conducted by the IRCCS Azienda Ospedaliero-Universitaria di Bologna and plans to enroll 50 patients undergoing biliary tract surgery. Participants will be patients who undergo biliary tract resection as part of their standard medical care, including procedures such as hepatectomy or duodenocephalopancreasectomy. Tissue samples collected during surgery will be processed and analyzed at the Pathological Anatomy unit using NGS technology. The 2-micron sections prepared from paraffin blocks of surgical tissue will be used for the sequencing investigations. Throughout the 36-month study period, clinical, serological, and imaging data relevant to the analyses will be collected. The primary outcome is to identify an NGS panel specific to dysplasia and CCA during the enrollment phase, which lasts up to 30 months. Participants will be closely monitored as part of their usual care, and the study will gather data to evaluate the diagnostic value of NGS in biliary tract tumors.
CONDITIONS
Brief Title
Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Availability of enough tissue for histological and NGS analysis (at least 20 ng DNA)
- Age greater than or equal to 18 years
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 months
Participants undergoing biliary tract resection as part of routine care have tissue samples collected and processed for next-generation sequencing analysis.
Tissue samples collected during surgery and processed afterwards
Duration - Up to 36 months
Clinical, serological, and instrumental data are collected to support the diagnostic analysis over the study period.
Data collected during routine care visits
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
F
Francecso Vasuri, MD
D
Deborah Malvi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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