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Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours

NCT ID: NCT06729944

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-27

Study Completion Date

2026-06-30

Brief Summary

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The aim of this study is to identify a dysplasia- and CCA-specific NGS panel to increase the diagnostic sensitivity of histological and/or cytological examination of biliary tract stenosis.

Detailed Description

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Patients undergoing biliary tract resection, as part of the normal course of care, at the O.U. General Surgery and Transplantation will be enrolled. Tissue samples will be processed and analysed at the O.U. of Pathological Anatomy.

Clinical, serological and instrumental data from patients, considered necessary for the intended analyses, will be collected for the purposes of the study.

The study will have a total duration of 36 months. It is planned to enrol 50 patients, all belonging to the U.O. Hepatobiliary and Transplant Surgery of the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The size of the population is estimated on the basis of the number of cases/year from the U.O. Hepatobiliary and Transplant Surgery, and is considered sufficient to achieve the primary objective, since it is an exploratory study. Surgical material (resection of biliary tract, possibly hepatectomy or duodenocephalopancreasectomy), which will be sampled according to clinical practice and sent to the O.U. of Pathological Anatomy of the IRCCS AOUBO, where it will be sampled, fixed in formalin, included in paraffin and processed. From paraffin blocks (selected from those obtained from the sampling of surgical pieces according to clinical practice) 2 µm sections will be cut for Next Generation Sequencing investigations.

Conditions

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Hepatectomy NGS Stenosis of Bile Duct

Keywords

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Next Generation Sequencing Stenosis of bile duct

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The patients' biological sample will be analysed by NGS and the results obtained will be compared with the morphological data
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients undergoing biliary tract resection

Patients undergoing biliary tract resection, as part of the normal care pathway, will be enrolled

Group Type EXPERIMENTAL

NGS

Intervention Type DIAGNOSTIC_TEST

Tissue samples will be processed and analysed at the U.O. of Pathological Anatomy

Interventions

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NGS

Tissue samples will be processed and analysed at the U.O. of Pathological Anatomy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Vasuri, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francecso Vasuri, MD

Role: CONTACT

Phone: 0512143761

Email: [email protected]

Deborah Malvi, MD

Role: CONTACT

Phone: 0512143761

Email: [email protected]

Facility Contacts

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Francesco Vasuri, MD

Role: primary

Other Identifiers

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RC 2022-2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BILgenetics_2022

Identifier Type: -

Identifier Source: org_study_id