The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

NCT ID: NCT06701214

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-28

Study Completion Date

2031-11-30

Brief Summary

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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

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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.

Conditions

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Clonal Hematopoiesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood collection

Blood will be taken from participants already undergoing blood collection

Intervention Type OTHER

Saliva collection

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Intervention Type OTHER

Bone marrow collection

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Alexander Bick

Assistant Professor Medicine, Division of Genetic Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Bick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University/Ingram Cancer Center

Locations

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Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vanderbilt-Ingram Services for Timely Access

Role: CONTACT

800-811-8480

Facility Contacts

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Vanderbilt-Ingram Service Services for Timely Access

Role: primary

800-811-8480

Other Identifiers

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NCI-2021-00704

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICCHEM20123

Identifier Type: -

Identifier Source: org_study_id

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