Clinical trial NCT05278520: Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
Official title: Studies on the Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Hip
Rheumatoid Arthritis
Keywords: Single-cell RNA sequencing
Spatial transcriptomics
Osteoarthritis
Rheumatoid arthritis
Spatial proteomics
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Hospital District of Helsinki and Uusimaa
First posted: 2022-03-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients of the HUS (Joint Authority of the Helsinki and Uusimaa Hospital District) Center of Arthroplasty and the Orto Surgical Hospital of Turku University.

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 omics.

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 focusing on the inflammatory responses, D) determine what are the key molecular pathways activated in OA.
2. To determine if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.
3. To map the whole transcriptome and proteome of OA and non-arthritic control tissue while keeping the morphological context with spatial omics technologies.
4. Further differentiation and identification of OA endotypes utilizing the single-cell and spatial omics 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characterization of cell populations in OA
timeFrame: Starting during the first quarter of 2025, ending by the last quarter of 2026.
measure: Comparison of cell populations between OA cases and controls
timeFrame: Starting during the first quarter of 2025, ending by the last quarter of 2026.
measure: Cellular landscape in OA
timeFrame: Starting during the last quarter of 2024, ending by the last quarter of 2026.
measure: Key molecular pathways of OA
timeFrame: Starting during the last quarter of 2025, ending by the last quarter of 2027.
measure: Comparison of disease mechanisms between RA and OA
timeFrame: Starting during the last quarter of 2024, ending by the last quarter of 2028.
Secondary outcomes:
measure: Biomarkers for OA
timeFrame: Starting during the second half of 2026, ending by the last quarter of 2028.
measure: OA endotypes
timeFrame: Starting during the first half of 2025, ending by the second half of 2027.
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
city: Turku
country: Finland
facility: PET-centre, University of Turku
state: Varsinais-Suomi
city: Turku
country: Finland
facility: Turku Bioscience, University of Turku
state: Varsinais-Suomi
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
affiliation: Turku Bioscience, University of Turku
name: Lea Mikkola, PhD
role: PRINCIPAL_INVESTIGATOR
References: