NCT05942807

Observational Monocentric Study on Biliary Tract Cancer (BABEL)

The Prognostic and Predictive Role of Clinical, Biochemical, Pathological and Molecular Characteristics of Patients With Biliary Tract Cancer: an Observational Monocentric Study. (BABEL)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 560 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Biliary Tract Cancer

Timeline

• Start date: 2021-05-15
• Primary completion: 2025-05-15
• Completion: 2026-05-01
• First posted: 2023-07-12
• Last updated: 2025-08-26

Locations

1 site across 1 country: Italy