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Search / Trial NCT04431024

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jun 13, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Germline Mutation In The Bap1 Gene Brca1 Associated Protein 1 Genetics Familial Background Natural History Dect

ClinConnect Summary

This clinical trial is looking at new ways to monitor people who have a specific genetic change called a BAP1 mutation, which is linked to a higher risk of developing mesothelioma and other cancers. The researchers want to see if using advanced imaging techniques, noninvasive tests from blood or saliva, and minimally invasive procedures can help detect these cancers earlier in individuals who are at risk.

To participate, individuals must be at least 30 years old and either have a history of cancer related to the BAP1 mutation or be a close relative of someone with this genetic change. Participants will undergo a variety of tests, including genetic counseling, physical exams, imaging scans, and possibly small procedures to look inside the chest or abdomen. They will visit the National Institutes of Health (NIH) once a year for follow-up. Participation in the study is ongoing, meaning there’s no fixed end date, allowing researchers to gather long-term data on these individuals’ health.

Gender

ALL

Eligibility criteria

  • * 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."

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

David S Schrump, M.D.

Principal Investigator

National Cancer Institute (NCI)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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