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

NCT05222854 | Active Not Recruiting

• 1 other identifier: CONGENIAL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The proportion of patients with actionable genomic alterations in all patients

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with gallbladder carcinoma

You may qualify if:

• Histologically confirmed diagnosis of incidental gallbladder carcinoma
• Patient ≥ 18 years old
• Patient already deceased
• Available tumor tissue (FFPE block)

You may not qualify if:

• Patient under 18 years of age

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead

Study Sites (1)

Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Frankfurt am Main, 60488, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

archival tumor tissue samples

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Thorsten Götze, Prof.

  Institute of clinical cancer research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 3, 2022
• Study Start: October 11, 2017
• Primary Completion: June 1, 2024
• Study Completion (Estimated): December 1, 2099
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)