OASEQ: Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis

Sponsor
University of Turku (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05278520
Collaborator
Turku University Hospital (Other), Helsinki University Central Hospital (Other)
65
42

Study Details

Study Description

Brief Summary

The purpose of this study is to cast light on the highly complex etiology and cellular landscape of hip osteoarthritis by utilising single-cell and spatial transcriptomics.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total hip arthroplasty

Detailed Description

The specific objectives of this project are:
  1. Using the latest single-cell RNA sequencing (scRNAseq) techniques the investigators aim to A) characterize what kind of cell populations are found in different synovial tissues and blood derived samples of OA patients, B) determine how the cell composition differs between arthritic and corresponding non-arthritic tissues, C) map the transcriptional and regulatory landscape of the cells mentioned in A and B, D) determine what are the key molecular pathways activated in OA.

  2. To determine if some of the blood-derived immune cell populations could be used as biomarkers for OA.

  3. To map the whole transcriptome of OA and non-arthritic control tissue while keeping the morphological context with spatial transcriptomics technologies.

  4. Further differentiation and identification of OA endotypes utilizing the single-cell and spatial data.

The project includes a Rheumatoid sub-study where the main objective is to compare arthritic tissue and peripheral blood constituents between OA and rheumatoid arthritis patients to explore the differences in the disease mechanisms.

Study Design

Study Type:
Observational
Anticipated Enrollment :
65 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Studies on the Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
OA cases

Twenty-five adult patients who have hip osteoarthritis.

Procedure: Total hip arthroplasty
Hip joint replacement surgery. Elective for RA and OA cases.

RA cases

Twenty-five adult patients who have rheumatoid arthritis in the hip joint.

Procedure: Total hip arthroplasty
Hip joint replacement surgery. Elective for RA and OA cases.

Non-arthritic controls

Fifteen adult patients who go through trauma-based emergency total hip arthroplasty and do not have arthritis.

Procedure: Total hip arthroplasty
Hip joint replacement surgery. Elective for RA and OA cases.

Outcome Measures

Primary Outcome Measures

  1. Characterization of cell populations in OA [Starting during the last quarter of 2022, ending by the last quarter of 2024.]

    Characterization of cell populations found in different synovial tissues and blood derived samples of OA patients utilising scRNAseq solutions.

  2. Comparison of cell populations between OA cases and controls [Starting during the last quarter of 2022, ending by the last quarter of 2024.]

    The investigators will determine how the cell composition differs between arthritic and corresponding non-arthritic tissues utilising scRNAseq solutions.

  3. Cellular landscape in OA [Starting during the second quarter of 2023, ending by the last quarter of 2024.]

    The investigators will map the transcriptional and regulatory landscape of OA at single-cell and tissue (spatial) level.

  4. Key molecular pathways of OA [Starting during the second quarter of 2023, ending by the last quarter of 2024.]

    The investigators will determine what are the key molecular pathways activated in OA.

  5. Comparison of disease mechanisms between RA and OA [Starting during the last quarter of 2022, ending by the last quarter of 2024.]

    In the Rheumatoid sub-study the investigators will explore the differences in the disease mechanisms between OA and RA by comparing synovial tissues and peripheral blood sample constituents.

Secondary Outcome Measures

  1. Biomarkers for OA [Starting during the second half of 2023, ending by the first half of 2025.]

    The investigators will investigate if some of the blood-derived immune cell populations could be used as biomarkers for OA.

  2. OA endotypes [Starting during the first half of 2024, ending by the second half of 2025.]

    The investigators aim to identify and further differentiate OA endotypes by utilizing the single-cell and spatial data.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria for the main (OA) study:

Cases: Adult patients with osteoarthritis in the hip joint and who are going through an elective total hip arthroplasty.

Controls: Non-arthritis adult patients who are going through a trauma-based emergency total hip arthroplasty.


Inclusion Criteria for the Rheumatoid sub-study:

Adult patients with rheumatoid arthritis in the hip joint and who are going through an elective total hip arthroplasty.


Exclusion Criteria:
  • The body mass index must be below 35

  • Age < 18 or > 74

  • The OA patients may not have diabetes, rheumatoid arthritis (RA), or metabolic syndrome.

For the Rheumatoid sub-study, the exclusion criteria are the same as above except for the RA.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Turku
  • Turku University Hospital
  • Helsinki University Central Hospital

Investigators

  • Principal Investigator: Lea Mikkola, PhD, University of Turku

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lea Mikkola, Principal Investigator, University of Turku
ClinicalTrials.gov Identifier:
NCT05278520
Other Study ID Numbers:
  • 2022OASEQ
First Posted:
Mar 14, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lea Mikkola, Principal Investigator, University of Turku
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022