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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Maria Gracia L Agra, R.N.
mariagracia.agra@nih.gov
(240) 858-3152
Backup
Raffit Hassan, M.D.
rh276q@nih.gov
(240) 760-6232
Time Frame
Start Date: 2019-03-13
Estimated Completion Date: 2027-07-05
Participants
Target number of participants: 1000
Treatments
1/Germline positive mesothelioma
Individuals with mesothelioma who have a BAP1 or other DNA repair/cancer predisposition mutation regardless of CLIA (or equivalent) confirmation
2/CLIA confirmed germline mutation without mesothelioma
Individuals with a CLIA (or equivalent) confirmed BAP1 or other DNA repair/cancer predisposition mutation who do not have a diagnosis of mesothelioma
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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