Long-term follow-up of mesothelioma patients with specific gene mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the natural and clinical history of patients with mesothelioma and their family members who have germline mutations in the BAP1 gene and other cancer predisposition genes. Participants, aged 2 and older, will be screened through medical and family history assessments and saliva tests. Those with mesothelioma will be part of the NIH Group, while others can choose to participate in either the NIH Group or a Remote Group, which involves annual phone contact and potential tumor tissue testing. The study seeks to understand how cancer develops in individuals with these genetic mutations.

Why it matters

Who can join: the full rules

* Inclusion Criteria for Genetic Testing:

Cohort 1:

* 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.

OR

* Participant with mesothelioma otherwise eligible for genetic testing in Cohort 2
* Age \>= 2 years

Cohort 2:

-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:

--A biological first degree relative (living or deceased) with a history of mesothelioma

OR

--A first degree biological relative with a CLIA (or equivalent) confirmed germline mutation in BAP1

OR

--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,

OR

--A second degree biological relative with mesothelioma and a CLIA (or equivalent) confirmed germline mutation in BAP1

-Age \>= 2 years

All participants must understand and be willing to sign a written informed consent

Exclusion Criteria for Genetic Testing

None

Inclusion Criteria for Surveillance:

Inclusion Criteria for Surveillance

* 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

Exclusion Criteria for Surveillance

None

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Raffit Hassan, M.D. — National Cancer Institute (NCI)
• Study coordinator: Cathy I Wagner, R.N.
• Email: cathy.wagner@nih.gov
• Phone: (240) 858-3159

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.