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10-Year study tracks hidden DNA changes that raise risk of cancer and heart disease

NCT ID NCT04102423

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 306 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Sep 2033

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

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.

clonal hematopoiesis of indeterminate potential Cytopenia Myelodysplastic Syndromes

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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Other studies related to the condition(s) this trial covers.