The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

Recruiting

• Conditions: Clonal Hematopoiesis

• Registration Number: NCT06701214
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Study Timeline

• Study Start: 2020-10-28
• Study First Submitted: 2024-04-18
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2030-11-30
• Study Completion: 2031-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CHIVE Registry	Up to approximately 120 months	Aggregate data will be utilized to better understand the association between clonal hematopoiesis and other conditions
CHIVE Biorepository	Up to approximately 120 months	Number of biological samples collected and stored (Blood, saliva, bone marrow) for future studies.

Trial Locations

Locations (1)

Vanderbilt University/Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States