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NCT04431024 · ClinicalTrials.gov registry record
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
A clinical trial of Mesothelioma and Familial Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 800
- Enrollment target
- 1
- Study location
NCT04431024: Recruiting study of Mesothelioma and Familial Cancer, sponsored by National Cancer Institute (NCI).
NCT04431024 is a study of Mesothelioma and Familial Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 800 participants, above the 181-participant average among 46 other Mesothelioma trials with a reported enrollment target (342% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04431024, a study of Mesothelioma and Familial Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 800 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2021-03-30 |
| Est. Completion | 2038-06-30 |
What NCT04431024 shows while recruiting
NCT04431024 is an observational study that tracks outcomes without assigning an intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 46 other Mesothelioma trials with a reported enrollment target (342% higher).
The record links to 4 conditions, with Mesothelioma appearing as the primary indexed condition, and to 0 interventions.
NCT04431024 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04431024 about?
NCT04431024 is a clinical study titled "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". 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 p...
What is the current status of trial NCT04431024?
This trial is currently recruiting. The enrollment target is 800 participants. The study started on 2021-03-30. Estimated completion is 2038-06-30.
What conditions does trial NCT04431024 study?
This clinical trial studies the following conditions: Mesothelioma, Familial Cancer, BRCA1-Associated Protein-1 (BAP1) Mutations, Tumor Predisposition Syndrome (TPDS).
Who is sponsoring clinical trial NCT04431024?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04431024 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04431024's enrollment target sits among peer trials
800 3rd of 46 higher than 44 of 46 other Mesothelioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mesothelioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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