Observational study on biliary tract cancer patients
The Prognostic and Predictive Role of Clinical, Biochemical, Pathological and Molecular Characteristics of Patients With Biliary Tract Cancer: an Observational Monocentric Study. (BABEL)
This study is trying to see if certain gene mutations in patients with biliary tract cancer can help predict how long they will live and how well they respond to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 560 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Rome) |
| Trial ID | NCT05942807 on ClinicalTrials.gov |
What this trial studies
BABEL is an observational, single-center, prospective study focusing on patients with biliary tract cancers treated at the Medical Oncology Unit of the FPUAG - IRCCS. The study aims to associate overall survival of these patients with IDH1/2 mutations, confirming their prognostic role in both metastatic and resectable disease settings. Additionally, it seeks to correlate FGFR mutations with overall survival and identify new clinical and molecular characteristics linked to treatment response. The study includes both a historical cohort and a prospective cohort for comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of biliary tract cancer and radiologically evident disease.
Not a fit: Patients without a histological diagnosis of biliary tract cancer or those lacking available clinical data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the genetic factors influencing survival in biliary tract cancer, potentially guiding personalized treatment strategies.
How similar studies have performed: While the specific approach of correlating IDH1/2 and FGFR mutations with survival in biliary tract cancer is novel, similar studies in other cancer types have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roma, Rome
- Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica — Roma, Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Lisa Salvatore, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Lisa Salvatore, MD, PhD
- Email: lisa.salvatore@policlinicogemelli.it
- Phone: 0630156318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.