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NCT Number: NCT05222854

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Frankfurt am Main, 60488, Germany

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. overall survival

    Time frame: 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).

  2. proportion of patients with genomic alterations

    Time frame: 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 outcomes

  1. The proportion of patients with actionable genomic alterations in all patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2024
Study completion
2099
First posted
Feb 3, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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