Primary Outcome Measures
- Incidence and frequencies of Cancers [ Time Frame: ongoing ]
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.
- Inclusion Criteria for Genetic Testing
-
- Cohort 1:</ul
- Subject with pathology confirming a diagnosis of mesothelioma.
-
- Subject must have a deleterious germline BAP1 mutation. Results from either research or clinical analyses are sufficient for this criterion.
-
- OR
-
- -Subject with mesothelioma otherwise eligible for genetic testing in Cohort 2
-
- OR
-
- Subject must have deleterious germline mutation in another DNA repair/cancer predisposition gene(s). Results from either research or clinical analyses are sufficient for this criterion.
-
- Age greater than or equal to 2 years
-
-
- Cohort 2</ul
- 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.
-
- OR
-
- -Individual with no history of mesothelioma with either:
-
- —A biological first degree relative (living or deceased) with a history of mesothelioma
-
- OR
-
- —A first degree biological relative with a CLIA confirmed germline mutation in BAP1
-
- OR
-
- —A first degree biological relative with mesothelioma and a CLIA confirmed germline mutation in another DNA-repair/cancer predisposition gene.
-
- OR
-
- A second degree biological relative with mesothelioma and a CLIA confirmed germline mutation in BAP1)
-
- -Age:
-
- Greater than or equal to 2 years for subjects with a first degree relative that has a germline mutation in p53
-
- Greater than or equal to 16 years for all other eligible potential mutations
-
- All participants or their legally authorized representatives (LARs) must understand and be willing to sign a written informed consent
-
-
- Inclusion Criteria for Surveillance
- Genetic testing criteria for respective cohorts must be met
- Subjects in Cohort 1 may be enrolled with positive results for germline BAP1 mutation or another DNA repair/cancer predisposition gene(s) regardless of CLIA confirmation
- Subjects in Cohort 2 must have CLIA confirmed germline BAP1 mutation or another DNA repair/cancer predisposition gene(s)
