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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 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. | The expected OS for BTC patients is 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Study population is consituited by patients with BTC treated at Medical Oncology Unit of the FPUAG - IRCCS. The study involves a historical cohort and a prospective cohort.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Salvatore, MD, PhD | Contact | 0630156318 | lisa.salvatore@policlinicogemelli.it | |
| Giovanni Trovato, MD | Contact | +390630156318 | giovanni.trovato@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Salvatore, MD, PhD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica | Recruiting | Roma | Rome | Italy |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| D004066 |
| Digestive System Diseases |