Bethesda, MDNCT04102423Now EnrollingIRB Ready

Clonal Hematopoiesis of Indeterminate Potential Clinical Trial in Bethesda, MD

Access cutting-edge clonal hematopoiesis of indeterminate potential treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related clonal hematopoiesis of indeterminate potential treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Clonal Hematopoiesis of Indeterminate Potential Study in Bethesda

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.

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Who Can Participate

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
17q or t(17p)
del(12p) or t(12p)
idic(X)(q13)
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT04102423) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Clonal Hematopoiesis of Indeterminate Potential Treatment Options in Bethesda, MD

If you're searching for clonal hematopoiesis of indeterminate potential treatment options in Bethesda, MD, this clinical trial (NCT04102423) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced clonal hematopoiesis of indeterminate potential specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all clonal hematopoiesis of indeterminate potential clinical trials near you to find additional studies recruiting in your area.

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