Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma"

Active, not recruiting

• Conditions: Gallbladder Carcinoma

• Registration Number: NCT05222854
• Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Brief Summary

Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it evaluate the efficacy or safety of the treatment decision made by the investigator.

Detailed Description

In the largest cohort of IGBC patients ever analysed in such a comprehensive approach

* determine the course of patients in this rare kind of cancer

* combine cGP analysis of histological tumor samples with clinical real-life data to get a comprehensive overview on IGBC patients analysed and evaluate data to identify possible further (targeted) treatment possibilities

* analyze potential risk factors associated with gallbladder carcinoma

* assess the frequency of targetable mutations in IGBC

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-06
• Study Completion: 2099-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Histologically confirmed diagnosis of incidental gallbladder carcinoma

• Patient ≥ 18 years old
• Patient already deceased
• Available tumor tissue (FFPE block)

Exclusion Criteria

Patient under 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	Through study completion, an average of 2 years	Overall Survival is defined as the time from date of first surgery, to the date of death (due to any cause).
proportion of patients with genomic alterations	Through study completion, an average of 2 years	The primary outcome variable of the molecular sub-project is the proportion of patients with actionable genomic alterations, defined as number of patients with actionable mutations divided by the number of patients with completed F1 CDx testing. Additionally, the two-sided 95% exact confidence interval (Clopper-Pearson) will be given.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with actionable genomic alterations in all patients	Through study completion, an average of 2 years	The proportion of patients with actionable genomic alterations in all patients, including those where no FoundationOne CDx test result may be obtained ± 95% confidence interval

Trial Locations

Locations (1)

Frankfurter Institut für Klinische Krebsforschung IKF GmbH; 🇩🇪 Frankfurt am Main, Germany