Observational Monocentric Study on Biliary Tract Cancer (BABEL)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Biliary Tract Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05942807

4173

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.