Back to search results

Observational Study for Early Mesothelioma Detection in BAP1 Tumor Predisposition Syndrome

This study is looking at better ways to find mesothelioma early in people who have a BAP1 gene mutation. This mutation increases your risk for certain cancers, including mesothelioma. Researchers want to see if using special CT scans (dual energy computed tomographic imaging, or DECT) and minimally invasive procedures can help detect mesothelioma sooner. They will follow participants for five years, gathering information on how well these methods work. You may be able to join if you are age 30 or older and have a known or suspected BAP1 gene mutation, or if you are a close relative of someone with this mutation.

Study design
This is an observational study planning to enroll 300 participants. It is not testing a new drug, but rather observing how certain imaging and surveillance methods work.
What's involved
Participants will be screened with a personal and family medical history, have their medical records reviewed, and provide a blood or saliva sample for BAP1 mutation testing. They will also receive genetic counseling.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed with annual or biennial check-ups, with an interim analysis at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04431024

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

Recruiting
Not specifiedAges 30+Observational
National Cancer Institute (NCI)
~300 participants
Updated 2026-09-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prospectively gather information related to the use of dual energy computed tomographic imaging (DECT) together with minimally invasive surveillance for early detection of mesotheliomas in patients with BAP1 TPDS
Measured over annual or biennial follow-up, 5 years interim analysis

Conditions

Familial Cancer
BRCA1-Associated Protein-1 (BAP1) Mutations
Tumor Predisposition Syndrome (TPDS)
Mesothelioma

Explore related trials

BAP1 Tumor Predisposition SyndromeMesothelial Neoplasm

NCT04431024

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • David S Schrump, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Rebecca B Alexander
[email protected]
(240) 781-4037
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Eligible participants include:
Individuals with a history of any malignancy with known or suspected germline mutations involving BAP1
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.
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."

What this trial measures

  • Prospectively gather information related to the use of dual energy computed tomographic imaging (DECT) together with minimally invasive surveillance for early detection of mesotheliomas in patients with BAP1 TPDSannual or biennial follow-up, 5 years interim analysis

    Documentation of the counts, incidence, and frequencies of cancers from dual energy computed tomographic imaging and minimally invasive surveillance results will be analyzed for statistical analysis for the early detection of mesotheliomas in patients with BAP1 TPDS.