Actively Recruiting

Age: 2Years +
All Genders
NCT03830229

Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes

Led by National Cancer Institute (NCI) · Updated on 2026-05-11

1000

Participants Needed

1

Research Sites

433 weeks

Total Duration

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AI-Summary

What this Trial Is About

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 certain gene mutations. Eligibility: -People ages 2 and older with a germline mutation in BAP1 or another gene that might cause cancer 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.

CONDITIONS

Official Title

Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant with pathology confirming a diagnosis of mesothelioma and a deleterious germline BAP1 mutation or another DNA repair/cancer predisposition gene mutation
  • Participant with mesothelioma otherwise eligible for genetic testing in Cohort 2
  • Age 2 years or older for participants with BAP1 or TP53 mutations or with a first degree relative having these mutations
  • Age 16 years or older for participants with other eligible mutations
  • Individual with a germline BAP1 mutation who does not have mesothelioma
  • Individual with no personal history of mesothelioma but with a first or second degree biological relative with mesothelioma or confirmed germline mutation in BAP1 or other DNA-repair/cancer predisposition gene
  • Willingness and ability to sign informed consent
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Maria Gracia L Agra, R.N.

CONTACT

R

Raffit Hassan, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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