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
| NCT ID | NCT04431024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Familial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-03-30 |
| Primary Completion | 2038-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2021-03-30 with a primary completion date of 2038-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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."
Contact & Investigator
David S Schrump, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT04431024 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 120 Years, studying Familial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04431024 currently recruiting?
Yes, NCT04431024 is actively recruiting participants. Contact the research team at rebecca.alexander@nih.gov for enrollment information.
Where is the NCT04431024 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04431024 clinical trial?
NCT04431024 is sponsored by National Cancer Institute (NCI). The principal investigator is David S Schrump, M.D. at National Cancer Institute (NCI). The trial plans to enroll 300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.