The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

NCT06701214 | Recruiting

• 2 other identifiers: VICCHEM20123NCI-2021-00704
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Clonal Hematopoiesis

Outcome Measures

Primary Outcomes (2)

• CHIVE Registry

  Aggregate data will be utilized to better understand the association between clonal hematopoiesis and other conditions

  Up to approximately 120 months

• CHIVE Biorepository

  Number of biological samples collected and stored (Blood, saliva, bone marrow) for future studies.

  Up to approximately 120 months

Interventions

Blood collection OTHER

Blood will be taken from participants already undergoing blood collection

Saliva collection OTHER

Undergo saliva collection

Bone marrow collection OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults \>/= 18 years old with a mutation known to cause clonal hematopoiesis or at a higher risk of having a clonal hematopoiesis mutation.

You may qualify if:

• 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)

You may not qualify if:

• Unable to provide consent

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexander Bick, MD, PhD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanderbilt-Ingram Services for Timely Access

CONTACT

800-811-8480; cip@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Medicine, Division of Genetic Medicine

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: November 22, 2024
• Study Start: October 28, 2020
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2031
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

US (1)