The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial population

Adults \>/= 18 years old with a mutation known to cause clonal hematopoiesis or at a higher risk of having a clonal hematopoiesis mutation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood collection

    Other intervention

    Blood will be taken from participants already undergoing blood collection

  • Saliva collection

    Other intervention

    Undergo saliva collection

  • Bone marrow collection

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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