Observational Monocentric Study on Biliary Tract Cancer (BABEL)
- Conditions
- Biliary Tract Cancer
- Registration Number
- NCT05942807
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 560
- Patients with biliary tract cancer;
- Patients with radiological evident disease;
- Patients >18 anni;
- Written informed consent;
- Patients with at least one oncological visit.
- Patients without available clinical data;
- Patients without histological diagnosis of BTC;
- Patients without written informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival The expected OS for BTC patients is 18 months OS is defined as the time between patient's date of diagnosis and date of death from any cause of the patient. For patients with no observed event, the follow-up time will be ended to the same date.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica
🇮🇹Roma, Rome, Italy