Clinical trial Recruiting at 1 site Observational Ages 18 and up

Observational study on biliary tract cancer patients

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)

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05942807 · Data updated 2026-11-12

This study is trying to see if certain gene mutations in patients with biliary tract cancer can help predict how long they will live and how well they respond to treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment560 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Roma, Rome)
StatusRecruiting
StartedMay 15, 2021
Main results expectedMay 15, 2025
Study endsMay 2026
Registry record updatedAugust 26, 2025
Trial IDNCT05942807 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of biliary tract cancer and radiologically evident disease.

Probably not a fit

Patients without a histological diagnosis of biliary tract cancer or those lacking available clinical data may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BABEL is an observational, single-center, prospective study focusing on patients with biliary tract cancers treated at the Medical Oncology Unit of the FPUAG - IRCCS. The study aims to associate overall survival of these patients with IDH1/2 mutations, confirming their prognostic role in both metastatic and resectable disease settings. Additionally, it seeks to correlate FGFR mutations with overall survival and identify new clinical and molecular characteristics linked to treatment response. The study includes both a historical cohort and a prospective cohort for comprehensive analysis.

Why it matters

Potential benefit: If successful, this study could provide insights into the genetic factors influencing survival in biliary tract cancer, potentially guiding personalized treatment strategies.

How similar studies have gone: While the specific approach of correlating IDH1/2 and FGFR mutations with survival in biliary tract cancer is novel, similar studies in other cancer types have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica
    Roma, Rome, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.