NCT06729944

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Apr 2023Jun 2026

Study Start

First participant enrolled

April 27, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 12, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

December 1, 2024

Last Update Submit

December 10, 2024

Conditions

HepatectomyNGSStenosis of Bile Duct

Keywords

Next Generation SequencingStenosis of bile duct

Outcome Measures

Primary Outcomes (1)

  • Identification of an NGS panel specific to dysplasia and CCA

    Ratio between the number of cases identified with NGS panel and the number of cases identified with standard of care

    During enrollment period, up to 30 months

Study Arms (1)

Patients undergoing biliary tract resection

EXPERIMENTAL

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

Diagnostic Test: NGS

Interventions

NGSDIAGNOSTIC_TEST

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

Patients undergoing biliary tract resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Availability of enough tissue for histological and NGS analysis (at least 20 ng DNA).
  • Age greater than/equal to 18 years.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

  • Francesco Vasuri, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francecso Vasuri, MD

CONTACT

0512143761francesco.vasuri2@unibo.it

Deborah Malvi, MD

CONTACT

0512143761deborah.malvi@aosp.bo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The patients' biological sample will be analysed by NGS and the results obtained will be compared with the morphological data
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 12, 2024

Study Start

April 27, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)