The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository
NCT ID: NCT06701214
Last Updated: 2024-11-22
Study Results
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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RECRUITING
800 participants
OBSERVATIONAL
2020-10-28
2031-11-30
Brief Summary
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Detailed Description
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* 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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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Alexander Bick
Assistant Professor Medicine, Division of Genetic Medicine
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
Countries
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Central Contacts
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Facility Contacts
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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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