Clincosm LogoSign in Get a demo

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

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05222854
Collaborator
(none)
200
Enrollment
1
Location
985.7
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Oct 11, 2017
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2099

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut für Klinische Krebsforschung IKF GmbH Frankfurt am Main Germany 60488

    Sponsors and Collaborators

    • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    Investigators

    • Principal Investigator: Thorsten Götze, PD Dr., Institute of clinical cancer research

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    ClinicalTrials.gov Identifier:
    NCT05222854
    Other Study ID Numbers:
    • CONGENIAL
    First Posted:
    Feb 3, 2022
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Gallbladder Neoplasms

    Study Results

    No Results Posted as of Feb 3, 2022