Monitoring for early detection of mesothelioma in patients with BAP1 mutations
Official title: Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome
Run by National Institutes of Health Clinical Center (CC) · NCT04431024 · Data updated 2026-11-12
This study is testing if advanced imaging and blood tests can help find mesothelioma early in people with BAP1 mutations who are at higher risk for this cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 120 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | March 30, 2021 |
| Main results expected | June 30, 2038 |
| Study ends | June 30, 2038 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT04431024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 30 and older with known or suspected germline BAP1 mutations or first- or second-degree relatives of affected individuals.
✕Probably not a fit
Patients without a history of malignancy or those under the age of 30 may not receive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of high-resolution dual energy computed tomographic imaging and noninvasive liquid biopsies for the early detection of mesotheliomas in individuals with BAP1 tumor predisposition syndrome. Participants, aged 30 and older, will undergo genetic testing to confirm the presence of BAP1 mutations and will be monitored over time through various assessments, including medical history reviews and physical exams. The study seeks to establish better surveillance protocols for those at high risk of developing mesothelioma and other cancers due to their genetic predisposition.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and monitoring strategies for patients at risk of mesothelioma due to BAP1 mutations.
How similar studies have gone: While there is ongoing research into genetic predispositions for cancer, this specific approach combining imaging and liquid biopsies for BAP1 mutations is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
* ELIGIBILITY CRITERIA: Inclusion Criteria for Genetic Testing -Eligible participants include: --Individuals with a history of any malignancy with known or suspected germline mutations involving BAP1 OR --First- or second-degree relatives of patients (with or without cancer) with documented BAP1 tumor predisposition syndrome (TPDS) * Age \>= 30 years. * All participants must understand and be willing to sign a written informed consent document. Inclusion Criteria for Surveillance * Eligible participants include those who completed step 1 genetic testing with study-confirmed BAP1 or other germline TPDS mutation. * Completed co-enrollment on protocol 06C0014, "Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies."
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: David S Schrump, M.D. — National Cancer Institute (NCI)
- Study coordinator: Rebecca B Alexander
- Email: rebecca.alexander@nih.gov
- Phone: (240) 781-4037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.