Status:

RECRUITING

Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Familial Cancer

BRCA1-Associated Protein-1 (BAP1) Mutations

Eligibility:

All Genders

30+ years

Brief Summary

Background: A germline mutation is a change to a person s genes that is carried through their DNA. These mutations can be passed on from parents to their offspring. Germline mutations in a gene calle...

Detailed Description

Background: * Mutations involving BRCA1-Associated Protein-1 (BAP1), a nuclear deubiquitinase involved in epigenetic regulation of gene expression, DNA repair, and cellular energetics, have emerged a...

Eligibility Criteria

Inclusion

  • ELIGIBILITY CRITERIA:
  • Inclusion Criteria for Genetic Testing
  • Eligible participants include:
  • -Individuals with a history of any malignancy with known or suspected germline mutations involving BAP1
  • OR
  • -First- or second-degree relatives of patients (with or without cancer) with documented BAP1 tumor predisposition syndrome (TPDS).
  • Age greater than or equal to 30 years.
  • All participants must understand and be willing to sign a written informed consent document.
  • Inclusion Criteria for Surveillance
  • Eligible participants include those who completed step 1 genetic testing with study-confirmed BAP1 or other germline TPDS mutation.
  • Completed co-enrollment on protocol 06C0014, "Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies."

Exclusion

    Key Trial Info

    Start Date :

    March 30 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2038

    Estimated Enrollment :

    800 Patients enrolled

    Trial Details

    Trial ID

    NCT04431024

    Start Date

    March 30 2021

    End Date

    June 30 2038

    Last Update

    December 24 2025

    Active Locations (1)

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    1

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892