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RecruitingNCT06701214CHIVEUpdated Sep 23, 2026

The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

An observational study in Clonal Hematopoiesis, sponsored by Vanderbilt-Ingram Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Vanderbilt-Ingram Cancer Center · Observational

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Clonal Hematopoiesis
03

In context

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient greater than or equal to 18 years old at time of consent
  • Able to provide
  • 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

Exclusion Criteria:

  • Unable to provide consent
  • Diagnosis of active hematologic . 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • OtherBlood collection

    Blood will be taken from participants already undergoing blood collection

  • OtherSaliva collection

    Undergo saliva collection

  • OtherBone marrow collection

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

06

What researchers measure

Primary outcomes

  1. CHIVE Registry

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

    Time frame: Up to approximately 120 months

  2. CHIVE Biorepository

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

    Time frame: Up to approximately 120 months

07

Study locations

1 of 1 sites recruiting
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37203, United States
    Recruiting
    • Vanderbilt-Ingram Service Services for Timely Access · Contactcip@vumc.org · 800-811-8480
    • Alexander Bick, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06701214
Responsible party
Alexander Bick (Assistant Professor Medicine, Division of Genetic Medicine, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
Nov 22, 2024
Start date
Oct 28, 2020
Primary completion
Nov 30, 2030 (estimated)
Completion
Nov 30, 2031 (estimated)
Last update
Sep 23, 2026

Study contacts

Vanderbilt-Ingram Services for Timely Access
Contact
cip@vumc.org
800-811-8480
Alexander Bick, MD, PhD
principal investigator · Vanderbilt University/Ingram Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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