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NCT Number: NCT05942807

Observational Monocentric Study on Biliary Tract Cancer (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.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica

Roma, Rome, Italy

Location status: Recruiting

Location contact

Lisa Salvatore, PhD

CONTACT

[email protected]

06-30156318

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Trovato, MD

CONTACT

[email protected]

+390630156318

Lisa Salvatore, MD, PhD

CONTACT

[email protected]

0630156318

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: BABEL

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2023
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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