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

Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma" the CONGENIAL Analysis Sub-study of the GR

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gallbladder Carcinoma

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60488
    • Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

adult patients with gallbladder carcinoma

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	Overall Survival is defined as the time from date of first surgery, to the date of death (due to any cause).	Through study completion, an average of 2 years
proportion of patients with genomic alterations	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.	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with actionable genomic alterations in all patients	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	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Investigators: Principal Investigator: Thorsten Götze, Prof., Institute of clinical cancer research

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2099

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Carcinoma; Gallbladder Neoplasms
• Other Study ID Numbers: CONGENIAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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