Status:
RECRUITING
CHIP/CCUS Natural History Protocol
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Clonal Hematopoiesis of Indeterminate Potential
Clonal Cytopenia of Undetermined Significance
Eligibility:
All Genders
18-99 years
Brief Summary
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 m...
Detailed Description
Clonal Hematopoiesis of Indeterminate Potential (CHIP) has been defined as the presence of a somatic pathogenic variant associated with hematological malignancy, with an allele fraction of at least 2%...
Eligibility Criteria
Inclusion
- 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
- Previous chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
March 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2033
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04102423
Start Date
March 3 2020
End Date
September 15 2033
Last Update
October 16 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892