Registry and biorepository for clonal hematopoiesis and its effects on health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.