Observational Monocentric Study on Biliary Tract Cancer (BABEL)

Biliary Tract Cancer Clinical Trial

— BABEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942807
• Other study ID #: 4173
• Status: Recruiting
• Start date: May 15, 2021
• Est. completion date: May 2026

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Lisa Salvatore, MD, PhD
• Phone: 0630156318
• Email: lisa.salvatore[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: May 2026
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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