Recruiting

Clonal Hematopoiesis

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT06701214

Conditions

Clonal Hematopoiesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood collection

Saliva collection

Bone marrow collection

Study Details

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

Study ID

NCT06701214

Start date

Oct 28, 2020

Status verified date

Nov, 2024

Completion date

Nov 30, 2031

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Interventions

Blood collection

Blood will be taken from participants already undergoing blood collection

Saliva collection

Undergo saliva collection

Bone marrow collection

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

Primary outcome measure

  • CHIVE Registry [ Time Frame: Up to approximately 120 months ]
  • CHIVE Biorepository [ Time Frame: Up to approximately 120 months ]

Central Contacts and Locations

Central contacts

Vanderbilt-Ingram Services for Timely Access

800-811-8480cip@vumc.org

Locations

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Vanderbilt-Ingram Service Services for Timely Access

800-811-8480cip@vumc.org

Principal Investigator:

Alexander Bick, MD, PhD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2024-11-22.