Long-Term Follow-Up for Mesothelioma and BAP1 Gene Mutations

This observational study is looking at people with mesothelioma and those with a germline mutation in the BAP1 gene. A germline mutation means you are born with a change in a gene, and BAP1 mutations can increase the risk of mesothelioma and other cancers. The study aims to understand how cancer develops in people with these BAP1 mutations. To join, you must be at least 2 years old and have a BAP1 germline mutation, or have mesothelioma and meet certain criteria for genetic testing. The main goal is to track the occurrence and frequency of cancers over time in these individuals and their families.

Study design
This is an observational study with a planned enrollment of 1000 participants. It is not specified if there are different treatment groups or if it is blinded.
What's involved
Participants will undergo screening, which includes providing medical and family history, and a saliva test. The study does not specify further visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
The study will track the incidence and frequencies of cancers on an ongoing basis.

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NCT03830229

Long Term Follow-Up of Patients With Mesothelioma and Individuals With Germline Mutations in BAP1

Recruiting
Not specifiedAges 2+Observational
National Cancer Institute (NCI)
~1,000 participants
Updated 2026-08-26 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and frequencies of Cancers
Measured over ongoing
Mesothelioma
Families

NCT03830229

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Raffit Hassan, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

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Eligibility criteria

Inclusion

Participant with pathology confirming a diagnosis of mesothelioma.
Participant must have a deleterious germline BAP1 mutation. Results from either research or clinical analyses are sufficient for this criterion.
Participant with mesothelioma otherwise eligible for genetic testing in Cohort 2
Age \>= 2 years
Individual with a germline BAP1 mutation who does not have a history of mesothelioma (other cancers are allowed). Results from either research or clinical analyses are sufficient for this criterion.
Individual with no history of mesothelioma with:
A biological first degree relative (living or deceased) with a history of mesothelioma
A first degree biological relative with a CLIA (or equivalent) confirmed germline mutation in BAP1
A second degree biological relative with a CLIA (or equivalent) confirmed germline mutation in BAP1 if relevant first degree relative is deceased or unavailable for testing,
A second degree biological relative with mesothelioma and a CLIA (or equivalent) confirmed germline mutation in BAP1
Age \>= 2 years
Genetic testing criteria including age restrictions for respective cohorts must be met.
Participants in Cohort 1 may be enrolled with positive results for germline BAP1 mutation regardless of CLIA (or equivalent) confirmation
Participants in Cohort 2:
must have CLIA (or equivalent) confirmed germline BAP1 mutation
  • Incidence and frequencies of Cancersongoing

    Standard exploratory and descriptive measures will be used. Counts, incidence, and frequencies of cancers identified via screening procedures on this trial will be reported, all in the context of an exploratory study with appropriate caveats.