Metabolic Profiling of Hematopoietic Stem Cells in Clonal... | NCT05246813

Studies
Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP)

NCT05246813

Sponsor

Imelda Hospital, Bonheiden

Status

Recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

Osteoporosis
Osteoarthritis, Hip
Hip Fractures
Clonal Hematopoiesis of Indeterminate Potential
Aging

Interventions

Blood and bone marrow cell collection

Countries

Belgium

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

Status Module

Record Verification Date

Mar 2026

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

Feb 11, 2022Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Feb 10, 2022

First Submission Date that Met QC Criteria

Feb 10, 2022

First Posted Date

Feb 18, 2022Actual

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

Mar 24, 2026

Last Update Posted Date

Mar 25, 2026Actual

Name	Class
Université Catholique de Louvain	OTHER

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

Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Osteoporotic hip fracture patients			Other: Blood and bone marrow cell collection
Hip osteoarthritis patients			Other: Blood and bone marrow cell collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood and bone marrow cell collection	Other	Collection of blood and bone marrow	Hip osteoarthritis patients Osteoporotic hip fracture patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES)		One day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 65 years and older

Exclusion Criteria:

known haematological condition (myelodysplasia, leukemia, cancer)
inability to provide written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing hip arthroplasty for hip osteoarthritis or osteoporotic hip fractures.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michaël R. Laurent, MD PhD	Contact	+32485143267		michael.laurent@imelda.be

Overall Officials

Name	Affiliation	Role
Nick Van Gastel, PhD	de Duve Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imelda Hospital	Recruiting	Bonheiden	België	2820	Belgium

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

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D015207	Osteoarthritis, Hip
D006620	Hip Fractures

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

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

Not provided

Browse Branches

Not provided