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Observational Study of CHIP/CCUS Natural History

This study is looking at people with Clonal Hematopoiesis of Indeterminate Potential (CHIP) or Clonal Cytopenia of Undetermined Significance (CCUS). CHIP is a change in your DNA that can increase your risk of blood cancers or heart disease, and CCUS is when you have low blood cell counts along with a DNA change. Researchers want to understand how these conditions progress over time. They will follow participants for 10 years to see if certain DNA changes are linked to blood cancers and heart disease, and to find other health connections. The study aims to enroll 306 adults aged 18 to 99 who have been diagnosed with CHIP.

Study design
This is an observational study, meaning researchers will watch how your condition progresses over time without giving any specific treatments. It aims to include 306 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years to track the association of myeloid somatic mutations with hematological malignancy, atherosclerosis, and immune response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04102423

CHIP/CCUS Natural History Protocol

Recruiting
Not specifiedAges 18–99Observational
National Heart, Lung, and Blood Institute (NHLBI)
~306 participants
Updated 2026-08-21 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Verify the previously studied association of myeloid somatic mutations with hematological malignancy
Measured over 10 years
+4 more outcomes measured

Conditions

Clonal Hematopoiesis of Indeterminate Potential
Clonal Cytopenia of Undetermined Significance

Explore related trials

Clonal Cytopenia of Undetermined SignificanceClonal Hematopoiesis of Indeterminate PotentialMyelodysplastic SyndromeSomatic pathogenic variant

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Emma M Groarke, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Chanelle A Hutchinson
[email protected]
(301) 827-1094
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Greater than or equal to 18 years of age
Willingness and capacity to provide written informed consent
Presence of a somatic pathogenic variant associated with hematological malignancy
Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant
Greater than 18 years of age
Willingness and capacity to provide written informed consent
Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of
Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant
Bone marrow aspirate and biopsy excluding hematological malignancy and MDS
Presence of a cytopenia for \>30 days
Hemoglobin, \<10 g/dL; platelet count, \<100 X10\^9 /L; or absolute neutrophil count, \<1.5 X10\^9 /L
At least 2 CBCs documented in a non-hospitalized patient at least 3 days apart

Exclusion

Known diagnosis of a hematological malignancy or bone marrow failure syndrome (excluding MGUS or MBL)
Presence of a cytopenia:
Hemoglobin, \<10 g/dL; platelet count, \<100 X 10\^9 /L; or absolute neutrophil count, \<1.5 X 10\^9 /L
Pregnant at the time of recruitment
Known diagnosis of a hematological malignancy or bone marrow failure syndrome (excluding MGUS or MBL)
Morphological evidence of dysplasia on bone marrow aspirate / biopsy 10% dysplastic cells in any hematopoietic lineage
Ringed sideroblasts \>15%
Presence of MDS defining cytogenetic abnormality
Del(7q)
del(5q)
17q or t(17p)
Del(13q)
del(11q)
del(12p) or t(12p)
del(9q)
idic(X)(q13)
t(11;16)
t(3;21)
t(1;3)
t(2;11)
inv(3)/t(3;3)
t(6;9)
Note: As a sole cytogenetic abnormality in the absence of morphological criteria, gain of chromosome 8, del(20q) and loss of chromosome Y are not considered definitive evidence of MDS.
Alternate hematological diagnosis causing cytopenia
Pregnant at time of recruitment

What this trial measures

  • Verify the previously studied association of myeloid somatic mutations with hematological malignancy10 years

    Association of myeloid somatic mutations with hematological malignancy

  • Verify the previously studied association of myeloid somatic mutations with atherosclerosis10 years

    Association of myeloid somatic mutations with atherosclerosis

  • Immune response10 years

    Assessing immune response by measuring markers of inflammation

  • Examine potential new clinical associations10 years

    New clinical associations

  • Development of cytopenia, hematological malignancy, and the size and stability of leucocyte somatic mutations10 years

    Cytopenia, hematological malignancy, and the size and stability of leucocyte somatic mutations