Registry and biorepository for clonal hematopoiesis and its effects on health
Discovering Outcomes in Clonal Hematopoiesis: The Clonal Hematopoiesis and Inflammation in VasculaturE (CHIVE) Registry and Biorepository
Vanderbilt-Ingram Cancer Center · NCT06701214
This study is trying to understand how clonal hematopoiesis affects health, especially heart risks and blood cancers, by collecting information and samples from patients with this condition or those at higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06701214 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between clonal hematopoiesis (CH) and various health conditions, particularly focusing on cardiovascular risks and hematologic malignancies. It will establish the CHIVE Registry to collect data from patients with CH or those at elevated risk, enhancing the understanding of clinical outcomes and co-morbidities associated with CH. Additionally, the study will create a biorepository for patient samples to facilitate research on the natural history of CH and its implications for health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clonal hematopoiesis, idiopathic cytopenia, or those at higher risk due to existing health conditions.
Not a fit: Patients with active hematologic malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of health risks associated with clonal hematopoiesis, potentially reducing the incidence of related diseases.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated that understanding clonal hematopoiesis can provide valuable insights into associated health risks.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient greater than or equal to 18 years old at time of consent * Able to provide informed consent * Idiopathic cytopenia (ICUS) or idiopathic cytoses (elevated blood counts without disease or explanation); clonal cytopenia of undetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or individuals at higher risk for clonal hematopoiesis (ex. patients with known diagnosis of solid tumors or cardiovascular disease) Exclusion Criteria: * Unable to provide consent * Diagnosis of active hematologic malignancy. For example, a diagnosis of CMML, AML, MDS, MPN; History of hematologic malignancy is NOT exclusionary if in complete remission (e.g. previous myeloma or lymphoma)
Where this trial is running
Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Alexander Bick, MD, PhD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Vanderbilt-Ingram Services for Timely Access
- Email: cip@vumc.org
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clonal Hematopoiesis