- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05278520
Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis (OASEQ)
Studies on the Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific objectives of this project are:
- 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.
- To determine if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.
- To map the whole transcriptome and proteome of OA and non-arthritic control tissue while keeping the morphological context with spatial omics technologies.
- 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lea Mikkola, PhD
- Phone Number: +358404143300
- Email: limikk@utu.fi
Study Locations
-
-
Uusimaa
-
Espoo, Uusimaa, Finland
- Recruiting
- Helsinki University Hospital
-
Contact:
- Anna Vasara, MD, PhD
- Email: anna.vasara@hus.fi
-
Principal Investigator:
- Anna Vasara, MD, PhD
-
-
Varsinais-Suomi
-
Turku, Varsinais-Suomi, Finland
- Active, not recruiting
- PET-centre, University of Turku
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Turku, Varsinais-Suomi, Finland
- Active, not recruiting
- Turku Bioscience, University of Turku
-
Turku, Varsinais-Suomi, Finland
- Recruiting
- Turku University Hospital
-
Contact:
- Pjotr Sarantsin, MD
- Email: Pjotr.Sarantsin@tyks.fi
-
Principal Investigator:
- Pjotr Sarantsin, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
OA cases
Fifty adult patients who have hip osteoarthritis.
|
Hip joint replacement surgery.
Elective for RA and OA cases.
|
|
RA cases
Forty adult patients who have rheumatoid arthritis in the hip joint.
|
Hip joint replacement surgery.
Elective for RA and OA cases.
|
|
Non-arthritic controls
Twenty adult patients who go through trauma-based emergency total hip arthroplasty and do not have arthritis.
|
Hip joint replacement surgery.
Elective for RA and OA cases.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterization of cell populations in OA
Time Frame: Starting during the first quarter of 2025, ending by the last quarter of 2026.
|
Characterization of cell populations found in different synovial tissues and blood derived samples of OA patients utilising single-cell RNA sequencing solutions.
|
Starting during the first quarter of 2025, ending by the last quarter of 2026.
|
|
Comparison of cell populations between OA cases and controls
Time Frame: Starting during the first quarter of 2025, ending by the last quarter of 2026.
|
The investigators will determine how the cell composition differs between arthritic and corresponding non-arthritic tissues utilising single-cell RNA sequencing solutions.
|
Starting during the first quarter of 2025, ending by the last quarter of 2026.
|
|
Cellular landscape in OA
Time Frame: Starting during the last quarter of 2024, ending by the last quarter of 2026.
|
The investigators will map the transcriptional, regulatory and protein landscape of OA at single-cell and tissue (spatial) level.
|
Starting during the last quarter of 2024, ending by the last quarter of 2026.
|
|
Key molecular pathways of OA
Time Frame: Starting during the last quarter of 2025, ending by the last quarter of 2027.
|
The investigators will determine what are the key molecular pathways activated in OA.
|
Starting during the last quarter of 2025, ending by the last quarter of 2027.
|
|
Comparison of disease mechanisms between RA and OA
Time Frame: Starting during the last quarter of 2024, ending by the last quarter of 2028.
|
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 2024, ending by the last quarter of 2028.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biomarkers for OA
Time Frame: Starting during the second half of 2026, ending by the last quarter of 2028.
|
The investigators will investigate if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.
|
Starting during the second half of 2026, ending by the last quarter of 2028.
|
|
OA endotypes
Time Frame: Starting during the first half of 2025, ending by the second half of 2027.
|
The investigators aim to identify and further differentiate OA endotypes by utilizing the single-cell and spatial data.
|
Starting during the first half of 2025, ending by the second half of 2027.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lea Mikkola, PhD, Turku Bioscience, University of Turku
Publications and helpful links
General Publications
- Rydgren E, Kotilainen SK, Piipponen M, Lönnberg T, Mikkola L. COMPARISON OF TWO HIGH-RESOLUTION SPATIAL TRANSCRIPTOMICS TECHNOLOGIES TO STUDY SYNOVIAL IMMUNE INFILTRATION IN OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS Osteoarthritis and Cartilage, Volume 33, Issue 6, 2025, page 816. https://doi.org/10.1016/j.joca.2025.03.079
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022OASEQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
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-
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-
AmgenTerminated
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AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
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University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
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Clinical Trials on Total hip arthroplasty
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University of ConnecticutCompletedOsteo Arthritis Knee | Hip Osteoarthritis | Protein-Energy Malnutrition | Orthopedic | Energy Malnutrition ProteinUnited States
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Orthopedic Hospital Vienna SpeisingCompletedTotal Hip ArthroplastyAustria
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Istanbul University - Cerrahpasa (IUC)CompletedObesity | ArthropathyTurkey
-
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-
Rothman Institute OrthopaedicsCompleted
-
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