The Clonal Hematopoiesis & Inflammation in Vasculature Re... | NCT06701214

Studies
The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

NCT06701214

Sponsor

Vanderbilt-Ingram Cancer Center

Status

Recruiting

Last Update Posted

Nov 22, 2024Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Clonal Hematopoiesis

Interventions

Blood collection
Saliva collection
Bone marrow collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-00704	Registry Identifier	NCI, Clinical Trials Reporting Program

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 28, 2020Actual

Primary Completion Date

Nov 30, 2030Estimated

Completion Date

Nov 30, 2031Estimated

First Submitted Date

Apr 18, 2024

First Submission Date that Met QC Criteria

Nov 20, 2024

First Posted Date

Nov 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2024

Last Update Posted Date

Nov 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexander Bick, Assistant Professor Medicine, Division of Genetic Medicine, Vanderbilt-Ingram Cancer CenterPrincipal Investigator

Lead Sponsor

Vanderbilt-Ingram Cancer CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Blood collection	Other	Blood will be taken from participants already undergoing blood collection
Saliva collection	Other	Undergo saliva collection
Bone marrow collection	Other	Bone marrow will be taken from participants already undergoing bone marrow collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CHIVE Registry	Aggregate data will be utilized to better understand the association between clonal hematopoiesis and other conditions	Up to approximately 120 months
CHIVE Biorepository	Number of biological samples collected and stored (Blood, saliva, bone marrow) for future studies.	Up to approximately 120 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanderbilt-Ingram Services for Timely Access	Contact	800-811-8480		cip@vumc.org

Overall Officials

Name	Affiliation	Role
Alexander Bick, MD, PhD	Vanderbilt University/Ingram Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University/Ingram Cancer Center	Recruiting	Nashville	Tennessee	37203	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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