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Trial Title:
Observational Monocentric Study on Biliary Tract Cancer (BABEL)
NCT ID:
NCT05942807
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Lisa Salvatore, PhD
Phone:
06-30156318
Email:
lisa.salvatore@policlinicogemelli.it
Start date:
May 15, 2021
Completion date:
May 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942807
