Actively Recruiting
Investigation of the Natural Progression of Clonal Hematopoiesis of Indeterminate Potential and Clonal Cytopenia of Undetermined Significance
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-05-22
306
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the natural progression of Clonal Hematopoiesis of Indeterminate Potential (CHIP) and Clonal Cytopenia of Undetermined Significance (CCUS). These are conditions involving changes in blood cell DNA that may increase the risk of blood cancers and cardiovascular disease, mainly affecting older adults. The study aims to verify known links between specific DNA mutations and diseases like atherosclerosis and blood cancers, and to discover new clinical associations. Participants include adults 18 and older with CHIP or CCUS who will undergo gene testing and other screening procedures. Those qualifying will provide blood and urine samples and may have bone marrow taken if they have CCUS. The study involves monitoring heart activity, neck artery ultrasounds, liver and heart scans, bone density scans, lung function tests, and tissue sampling from the cheek or skin. Optional advanced scans of the heart and full body may be performed. Participants are grouped based on their condition and specific mutations. Participants will have yearly follow-up visits for 10 years, repeating various tests every 1 to 3 years. Researchers will monitor immune response, progression to blood cancers or cytopenia, and the stability of DNA mutations. They will also assess associations with chronic infections, metabolic conditions, vitamin levels, kidney, lung, and liver health. This long-term observation aims to improve understanding of CHIP and CCUS and guide future management strategies.
CONDITIONS
Brief Title
CHIP/CCUS Natural History Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing and able to provide written informed consent
- Presence of a somatic pathogenic variant associated with blood cancers
- Variant allele fraction of 2% or higher in at least one identified mutation
- For CCUS: bone marrow biopsy excluding blood cancer and evidence of cytopenia for more than 30 days
- At least two complete blood counts documented at least 3 days apart for CCUS
You will not qualify if you...
- Known diagnosis of blood cancer or bone marrow failure syndrome (except MGUS or MBL)
- Hemoglobin below 10 g/dL, platelet count below 100 x 10^9/L, or neutrophil count below 1.5 x 10^9/L
- Pregnant at time of recruitment
- For CCUS: morphological evidence of dysplasia with 10% or more dysplastic cells
- Ringed sideroblasts over 15%
- Presence of specific MDS-defining cytogenetic abnormalities
- Alternate blood disorder causing cytopenia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants with CHIP or CCUS are observed over time to study the natural progression of their condition and related health outcomes.
Periodic visits depending on clinical needs
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Tania R Machado
E
Emma M Groarke, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here