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NCT04102423 · ClinicalTrials.gov registry record
CHIP/CCUS Natural History Protocol
A clinical trial of Clonal Cytopenia of Undetermined Significance and Clonal Hematopoiesis of Indeterminate Potential, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- 306
- Enrollment target
- 1
- Study location
NCT04102423: Recruiting study of Clonal Cytopenia of Undetermined Significance and Clonal Hematopoiesis of Indeterminate Potential, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT04102423 is a study of Clonal Cytopenia of Undetermined Significance and Clonal Hematopoiesis of Indeterminate Potential that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 306 participants, below the 409-participant average among 11 other Clonal Cytopenia of Undetermined Significance trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04102423, a study of Clonal Cytopenia of Undetermined Significance and Clonal Hematopoiesis of Indeterminate Potential, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- 306 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Clonal Hematopoiesis of Indeterminate Potential (CHIP) is a change in a person s DNA that can increase a person s risk of developing blood cancers or cardiovascular disease. CHIP occurs mostly occurs in older people. Clonal cytopenia of undetermined significance (CCUS) occurs when one or more blood cell types is lower than it should be and is associated with a change in their DNA. Researchers want to learn more about how CHIP and CCUS progress. Objective: To examine the natural history of people in a study of CHIP and CCUS to (1) verify the association of myeloid somatic mutations with atherosclerosis and blood cancers, and (2) find new potential clinical associations. Eligibility: Adults 18 and older with CHIP with a somatic pathogenic variant associated with blood cancers. Adults with CCUS are also needed. Design: Potential participants will be screened with gene testing. For this, they will give a blood sample. They will also be enrolled in NHLBI screening protocol #97-H-0041. Those who pass this screening will visit the NIH Clinical Center for more screening tests. For this, they will give a blood sample. They will have a physical exam. They will give their medical history. They may give a urine sample. Those with CCUS will have bone marrow taken. Eligible participants will give blood and urine samples. Their heart activity will be monitored and tested. The arteries in their neck will be assessed using ultrasound. They will have liver and heart scans. They will have a bone mineral density scan. They will have lung function tests. They will have the inside of their cheek swabbed or have a skin punch biopsy. They will have the option to have advanced scans done of their heart and full body but this is not required. Participants will have yearly follow-up visits for 10 years. They will repeat the above procedures every 1-3 years depending on the procedure.
Primary Outcome
Association of myeloid somatic mutations with hematological malignancy
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2020-03-03 |
| Est. Completion | 2033-09-15 |
What NCT04102423 shows while recruiting
NCT04102423 is an observational study that tracks outcomes without assigning an intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, below the 409-participant average among 11 other Clonal Cytopenia of Undetermined Significance trials with a reported enrollment target (25% lower).
The record links to 2 conditions, with Clonal Cytopenia of Undetermined Significance appearing as the primary indexed condition, and to 0 interventions.
NCT04102423 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04102423 about?
NCT04102423 is a clinical study titled "CHIP/CCUS Natural History Protocol". Background: Clonal Hematopoiesis of Indeterminate Potential (CHIP) is a change in a person s DNA that can increase a person s risk of developing blood cancers or cardiovascular disease. CHIP occurs mostly occurs in older people. Clonal cytopenia of undetermined significance (CCUS) occurs when one o...
What is the current status of trial NCT04102423?
This trial is currently recruiting. The enrollment target is 306 participants. The study started on 2020-03-03. Estimated completion is 2033-09-15.
What conditions does trial NCT04102423 study?
This clinical trial studies the following conditions: Clonal Cytopenia of Undetermined Significance, Clonal Hematopoiesis of Indeterminate Potential.
Who is sponsoring clinical trial NCT04102423?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04102423 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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Where NCT04102423's enrollment target sits among peer trials
306 3rd of 11 higher than 9 of 11 other Clonal Cytopenia of Undetermined Significance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clonal Cytopenia of Undetermined Significance 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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