Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis

Rheumatoid Arthritis Clinical Trial

— OASEQ  

Official title:

Studies on the Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278520
• Other study ID #: 2022OASEQ
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: University of Turku
• Contact: Lea Mikkola, PhD
• Phone: +358404143300
• Email: limikk[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

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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.

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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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Osteoarthritis, Hip
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Espoo	Uusimaa
Finland	PET-centre, University of Turku	Turku	Varsinais-Suomi
Finland	Turku Bioscience, University of Turku	Turku	Varsinais-Suomi
Finland	Turku University Hospital	Turku	Varsinais-Suomi

Sponsors (3)

Lead Sponsor	Collaborator
University of Turku	Helsinki University Central Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of cell populations in OA	Characterization of cell populations found in different synovial tissues and blood derived samples of OA patients utilising scRNAseq solutions.	Starting during the last quarter of 2022, ending by the last quarter of 2024.
Primary	Comparison of cell populations between OA cases and controls	The investigators will determine how the cell composition differs between arthritic and corresponding non-arthritic tissues utilising scRNAseq solutions.	Starting during the last quarter of 2022, ending by the last quarter of 2024.
Primary	Cellular landscape in OA	The investigators will map the transcriptional and regulatory landscape of OA at single-cell and tissue (spatial) level.	Starting during the second quarter of 2023, ending by the last quarter of 2024.
Primary	Key molecular pathways of OA	The investigators will determine what are the key molecular pathways activated in OA.	Starting during the second quarter of 2023, ending by the last quarter of 2024.
Primary	Comparison of disease mechanisms between RA and OA	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.	Starting during the last quarter of 2022, ending by the last quarter of 2024.
Secondary	Biomarkers for OA	The investigators will investigate if some of the blood-derived immune cell populations could be used as biomarkers for OA.	Starting during the second half of 2023, ending by the first half of 2025.
Secondary	OA endotypes	The investigators aim to identify and further differentiate OA endotypes by utilizing the single-cell and spatial data.	Starting during the first half of 2024, ending by the second half of 2025.