Biliary Tract Cancer
Conditions
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.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactLisa Salvatore, MD, PhD
Backup ContactGiovanni Trovato, MD
Outcome results
None listed