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

• Sponsor: Imelda Hospital, Bonheiden (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05246813
• Collaborator: Université Catholique de Louvain (Other)
• Enrollment: 24
• Location: 1
• Anticipated Duration (Months): 46.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Osteoarthritis, Hip; Hip Fractures; Clonal Hematopoiesis of Indeterminate Potential; Aging	Other: Blood and bone marrow cell collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 24 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP): a Prospective Observational Study
• Actual Study Start Date: Feb 11, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Osteoporotic hip fracture patients	Other: Blood and bone marrow cell collection; Collection of blood and bone marrow
Hip osteoarthritis patients	Other: Blood and bone marrow cell collection; Collection of blood and bone marrow

Outcome Measures

Primary Outcome Measures

1. Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES) [One day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 65 years and older

Exclusion Criteria:

• known haematological condition (myelodysplasia, leukemia, cancer)

• inability to provide written informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imelda Hospital	Bonheiden	België	Belgium	2820

Sponsors and Collaborators

• Imelda Hospital, Bonheiden
• Université Catholique de Louvain

Investigators

• Principal Investigator: Nick Van Gastel, PhD, de Duve Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michaël R Laurent, MD PhD, Principal Investigator, Imelda Hospital, Bonheiden
• ClinicalTrials.gov Identifier: NCT05246813
• Other Study ID Numbers: 20211214
• First Posted: Feb 18, 2022
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoporosis; Osteoarthritis, Hip; Hip Fractures

Study Results

No Results Posted as of Feb 18, 2022