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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

National Cancer Institute (NCI) · NCT04431024

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–120 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
300
US sites recruiting
1
Study start
March 30, 2021
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Background

A germline mutation is a change to a person s genes that is carried through their DNA. These mutations can be passed on from parents to their offspring. Germline mutations in a gene called BAP1 are linked to the development of mesothelioma and other cancers. Researchers want to follow people with these mutations to learn more.

Objective

To see if researchers can improve how people who have or are suspected to have a BAP1 mutation are monitored over time.

Eligibility

People age 30 and older who are suspected to have a BAP1 germline mutation.

Design

Participants will be screened with a personal and family medical history. Their medical records may be reviewed. They will give a blood or saliva sample to test for a BAP1 mutation. They will get genetic counseling.

To take part in this study, participants will enroll on 2 to 3 other protocols.

Participants will have a physical exam. They may have a tumor biopsy. They will give blood and urine samples. They will have skin and eye exams.

Some participants will have video-assisted thoracoscopy to examine the chest and lungs and diagnose suspicious areas. For this, a small camera is inserted into the chest through a small incision.

Some participants will have laparoscopy to examine the organs inside the abdomen. For this, a small camera is inserted into the abdomen through a small incision.

Participants will have imaging scans of the chest, abdomen, and pelvis. They may have brain scans.

Participants will visit the NIH once a year for follow-up exams.

Participation lasts indefinitely....

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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."

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · 888-624-1937

Study contacts (from the official record)

  • Rebecca B Alexander · (240) 781-4037 · rebecca.alexander@nih.gov
  • David S Schrump, M.D. · (240) 760-6239 · david_schrump@nih.gov
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