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Recruiting

NCT Number: NCT06701214

The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

Location status: Recruiting

Location contact

Alexander Bick, MD, PhD

PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Service Services for Timely Access

CONTACT

[email protected]

800-811-8480

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. CHIVE Registry

    Time frame: Up to approximately 120 months

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

  2. CHIVE Biorepository

    Time frame: Up to approximately 120 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vanderbilt-Ingram Services for Timely Access

CONTACT

[email protected]

800-811-8480

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Registry information

Official study title

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

Acronym: CHIVE

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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