CHIP/CCUS Natural History Protocol
Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Sep 24, 2019
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
The CHIP/CCUS Natural History Protocol is a clinical trial designed to understand two conditions: Clonal Hematopoiesis of Indeterminate Potential (CHIP) and Clonal Cytopenia of Undetermined Significance (CCUS). CHIP is a change in DNA that can increase the risk of blood cancers and heart disease, while CCUS involves having lower levels of certain blood cells. Researchers aim to learn how these conditions develop over time and how they may be linked to other health issues.
To participate, you must be at least 18 years old and have specific DNA changes associated with these conditions. Participants will go through several health tests, including blood and urine samples, heart and lung function tests, and scans of the liver and heart. If you qualify, you will attend follow-up visits at least once a year for up to 10 years, where you'll repeat some of these tests. This trial is currently recruiting participants, and it's a valuable opportunity to contribute to important research that could help improve understanding and treatment of these conditions.
Gender
ALL
Eligibility criteria
- * 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
- • Treatment with previous chemotherapy or radiotherapy
- 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
About National Heart, Lung, And Blood Institute (Nhlbi)
The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Trial Officials
Emma M Groarke, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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