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

Gallbladder Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05222854
• Other study ID #: CONGENIAL
• Status: Active, not recruiting
• Start date: October 11, 2017
• Est. completion date: December 2099

Study information

• Verified date: March 2024
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2099
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Gallbladder Carcinoma
• Gallbladder Neoplasms

Locations

Country	Name	City	State
Germany	Frankfurter Institut für Klinische Krebsforschung IKF GmbH	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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