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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 560 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Rome) |
| Status | Recruiting |
| Started | May 15, 2021 |
| Main results expected | May 15, 2025 |
| Study ends | May 2026 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT05942807 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
- Principal investigator: Lisa Salvatore, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Lisa Salvatore, MD, PhD
- Email: lisa.salvatore@policlinicogemelli.it
- Phone: 0630156318
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.