Observational Monocentric Study on Biliary Tract Cancer (BABEL)

NCT ID: NCT05942807

Last Updated: 2025-08-26

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

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-15

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Biliary Tract Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Salvatore, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

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Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica

Roma, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lisa Salvatore, MD, PhD

Role: CONTACT

0630156318

Giovanni Trovato, MD

Role: CONTACT

+390630156318

Facility Contacts

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Lisa Salvatore, PhD

Role: primary

06-30156318

Other Identifiers

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4173

Identifier Type: -

Identifier Source: org_study_id

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