The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood collection, Saliva collection, Bone marrow collection.
- Who it may be relevant to
- Registry conditions: Clonal Hematopoiesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Discovering Outcomes in Clonal Hematopoiesis: The Clonal Hematopoiesis and Inflammation in VasculaturE (CHIVE) Registry and Biorepository
Overview
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
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.
Interventions
- Other Blood collection
Blood will be taken from participants already undergoing blood collection - Other Saliva collection
Undergo saliva collection - Other Bone marrow collection
Bone marrow will be taken from participants already undergoing bone marrow collection
Primary outcome measures
- CHIVE Registry [Time frame: Up to approximately 120 months]
- CHIVE Biorepository [Time frame: Up to approximately 120 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Vanderbilt University/Ingram Cancer Center — Nashville
Identifiers
NCT: NCT06701214 · VICCHEM20123 · NCI-2021-00704