10-Year study tracks hidden DNA changes that raise risk of cancer and heart disease
NCT ID NCT04102423
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This study follows 306 adults with certain DNA changes in their blood cells (called CHIP or CCUS) to see how these changes affect health over time. Researchers want to learn if these changes increase the risk of blood cancers or heart problems. Participants will have yearly check-ups for up to 10 years, including blood tests, heart scans, and other health monitoring.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 306 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Primary Clinical
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Participants with Clonal Hematopoiesis of Indeterminate Significance (CHIP): INCLUSION CRITERIA: * 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 EXCLUSION CRITERIA: * 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 Participants with Clonal Cytopenia of Uncertain Significance (CCUS): INCLUSION CRITERIA: * 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 myelodysplasia and without a MDS defining cytogenetic abnormality * 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 CRITERIA: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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