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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-120
SponsorNational Cancer Institute (NCI)

About this trial

Background:

-A gene provides instructions to the body. Mutated genes can sometimes cause cancer. Germline mutations are those people are born with. These mutations in the BAP1 gene can cause mesothelioma and other cancers. Researchers want to study people with germline mutations of BAP1 and other genes known to cause cancer.

Objective:

-To learn how cancer might develop in people with BAP1 mutations.

Eligibility:

-People ages 2 and older with a germline mutation in BAP1

Design:

* Participants will be screened with:

* Medical and family history * Saliva test * Participants with mesothelioma will be in the NIH Group. Participants without mesothelioma can choose to be in either the NIH Group or the Remote Group. * Remote Group participants will have a medical and family history by phone. If they have tumor tissue from a previous surgery, it will be tested. They will be contacted once a year by phone. * NIH Group participants will have a baseline visit. This can take up to 4 days. They may have to stay in the area overnight. The visit will include:

* Physical exam * Evaluation of tumor tissue if available * Optional tumor biopsy * Blood tests * Scans: A machine will take pictures of the body. * Photographs of skin lesions or other issues * Skin exam * Eye exam * NIH Group participants will have visits once or twice a year. These will include a physical exam, lab tests, scans, and other tests as needed. * Participants who have a confirmed mutation will be asked to contact any relatives who may be at risk and ask them about joining the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

must have CLIA (or equivalent) confirmed germline BAP1 mutation

Trial population

Persons with mesothelioma and family members as well as individuals with CLIA documented germline BAP-1.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: 1/Germline positive mesothelioma
Group B: 2/CLIA confirmed germline mutation without mesothelioma

Trial outcomes

Primary outcomes

1

Incidence and frequencies of Cancers

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.

Time frame
ongoing

Secondary outcomes

Other outcomes

Sponsors and contacts

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