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Observational Monocentric Study on Biliary Tract Cancer (BABEL)

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05942807
Collaborator
(none)
560
Enrollment
1
Location
59.5
Anticipated Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BABEL is an observational, single-center, prospective study about patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    BABEL is an observational, single-center, prospective study with an historical cohort. Study population is represented by patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS. The study involves an historical cohort and a prospective cohort. Primary aim of the study is to associate BTC patients' overall survival with IDH1/2 mutations, in order to confirm the prognostic role of these genes both metastatic and resectable disease setting. The secondary aims are to correlate FGFR mutations and overall survival of BTC patients and to find new clinical and molecular characteristics linked with survival and response to treatment.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    560 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Prognostic and Predictive Role of Clinical, Biochemical, Pathological and Molecular Characteristics of Patients With Biliary Tract Cancer: an Observational Monocentric Study. (BABEL)
    Actual Study Start Date :
    May 15, 2021
    Anticipated Primary Completion Date :
    May 15, 2025
    Anticipated Study Completion Date :
    May 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [The expected OS for BTC patients is 18 months]

      OS is defined as the time between patient's date of diagnosis and date of death from any cause of the patient. For patients with no observed event, the follow-up time will be ended to the same date.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with biliary tract cancer;

    • Patients with radiological evident disease;

    • Patients >18 anni;

    • Written informed consent;

    • Patients with at least one oncological visit.

    Exclusion Criteria:

    • Patients without available clinical data;

    • Patients without histological diagnosis of BTC;

    • Patients without written informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica Roma Rome Italy

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05942807
    Other Study ID Numbers:
    • 4173
    First Posted:
    Jul 12, 2023
    Last Update Posted:
    Jul 12, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Biliary Tract Neoplasms

    Study Results

    No Results Posted as of Jul 12, 2023