Observational Monocentric Study on Biliary Tract Cancer (BABEL) (BABEL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Biliary Tract Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 560

Contacts and Locations

• Study Contact: Name: Lisa Salvatore, MD, PhD; Phone Number: 0630156318; Email: lisa.salvatore@policlinicogemelli.it
• Study Contact Backup: Name: Giovanni Trovato, MD; Phone Number: +390630156318; Email: giovanni.trovato@guest.policlinicogemelli.it

Study Locations

• Italy
  • Rome
    • Roma, Rome, Italy
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica
      • Contact: Lisa Salvatore, PhD; Phone Number: 06-30156318; Email: lisa.salvatore@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Lisa Salvatore, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): May 15, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: 4173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No