Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03830229|
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : January 23, 2023
-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.
-To learn how cancer might develop in people with certain gene mutations.
-People ages 2 and older with a germline mutation in BAP1 or another gene that might cause cancer
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes|
|Actual Study Start Date :||March 13, 2019|
|Estimated Primary Completion Date :||July 6, 2026|
|Estimated Study Completion Date :||July 5, 2027|
1/Germline positive mesothelioma
Individuals with mesothelioma who have a BAP1 or other DNA repair/cancer predisposition mutation regardless of CLIA confirmation
2/CLIA confirmed germline mutation without mesothelioma
Individuals with a CLIA confirmed BAP1 or other DNA repair/cancer predisposition mutation who do not have a diagnosis of mesothelioma
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830229
|Contact: Maria G Agra, R.N.||(240) firstname.lastname@example.org|
|Contact: Raffit Hassan, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Raffit Hassan, M.D.||National Cancer Institute (NCI)|