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The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

Discovering Outcomes in Clonal Hematopoiesis: The Clonal Hematopoiesis and Inflammation in VasculaturE (CHIVE) Registry and Biorepository

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06701214
Acronym
CHIVE
Enrollment
800
Registered
2024-11-22
Start date
2020-10-28
Completion date
2031-11-30
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clonal Hematopoiesis

Brief summary

This study will investigate the association between clonal hematopoiesis and other conditions. Clonal hematopoiesis (CH) refers to the mutations in a person's stem cells which commonly affect people as they get older. These mutations have notably been linked to increased risk of certain cancers as well as increased risk of heart disease.

Detailed description

Objectives: * To develop the CHIVE Registry with CH patients or patients with elevated risk for CH in order to better characterize associated clinical outcomes and co-morbidities in these populations * To improve understanding of cardiovascular phenotypes and risk of patients with known Clonal Hematopoiesis of indeterminate potential (CHIP) or Clonal Cytopenias of undetermined significance (CCUS) * To investigate prognostic significance of CH mutations for the development hematologic malignancies * To generate a CHIVE Biorepository to acquire patient samples to study the natural history of CH, and to make available to CH investigators.

Interventions

OTHERBlood collection

Blood will be taken from participants already undergoing blood collection

OTHERSaliva collection

Undergo saliva collection

Bone marrow will be taken from participants already undergoing bone marrow collection

Sponsors

Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
CHIVE RegistryUp to approximately 120 monthsAggregate data will be utilized to better understand the association between clonal hematopoiesis and other conditions
CHIVE BiorepositoryUp to approximately 120 monthsNumber of biological samples collected and stored (Blood, saliva, bone marrow) for future studies.

Countries

United States

Contacts

Primary ContactVanderbilt-Ingram Services for Timely Access
cip@vumc.org800-811-8480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026