Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05278520
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Hip joint synovial tissues and bone, peripheral blood mononuclear cells, serum, plasma, and whole blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of cell populations in OA', 'timeFrame': 'Starting during the first quarter of 2025, ending by the last quarter of 2026.', 'description': 'Characterization of cell populations found in different synovial tissues and blood derived samples of OA patients utilising single-cell RNA sequencing solutions.'}, {'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.', 'description': 'The investigators will determine how the cell composition differs between arthritic and corresponding non-arthritic tissues utilising single-cell RNA sequencing solutions.'}, {'measure': 'Cellular landscape in OA', 'timeFrame': 'Starting during the last quarter of 2024, ending by the last quarter of 2026.', 'description': 'The investigators will map the transcriptional, regulatory and protein landscape of OA at single-cell and tissue (spatial) level.'}, {'measure': 'Key molecular pathways of OA', 'timeFrame': 'Starting during the last quarter of 2025, ending by the last quarter of 2027.', 'description': 'The investigators will determine what are the key molecular pathways activated in OA.'}, {'measure': 'Comparison of disease mechanisms between RA and OA', 'timeFrame': 'Starting during the last quarter of 2024, ending by the last quarter of 2028.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Biomarkers for OA', 'timeFrame': 'Starting during the second half of 2026, ending by the last quarter of 2028.', 'description': 'The investigators will investigate if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.'}, {'measure': 'OA endotypes', 'timeFrame': 'Starting during the first half of 2025, ending by the second half of 2027.', 'description': 'The investigators aim to identify and further differentiate OA endotypes by utilizing the single-cell and spatial data.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single-cell RNA sequencing', 'Spatial transcriptomics', 'Osteoarthritis', 'Rheumatoid arthritis', 'Spatial proteomics'], 'conditions': ['Osteoarthritis, Hip', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The specific objectives of this project are:\n\n1. 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.\n2. To determine if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.\n3. To map the whole transcriptome and proteome of OA and non-arthritic control tissue while keeping the morphological context with spatial omics technologies.\n4. Further differentiation and identification of OA endotypes utilizing the single-cell and spatial omics data.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for the main (OA) study:\n\nCases: Adult patients with osteoarthritis in the hip joint and who are going through an elective total hip arthroplasty.\n\nControls: Non-arthritis adult patients who are going through a trauma-based emergency total hip arthroplasty.\n\n\\----\n\nInclusion Criteria for the Rheumatoid sub-study:\n\nAdult patients with rheumatoid arthritis in the hip joint and who are going through an elective total hip arthroplasty.\n\n\\----\n\nExclusion Criteria:\n\n* The body mass index must be below 35\n* Age \\< 18 or \\> 74\n* The OA patients may not have diabetes, rheumatoid arthritis (RA), or metabolic syndrome.\n\nFor the Rheumatoid sub-study, the exclusion criteria are the same as above except for the RA.'}, 'identificationModule': {'nctId': 'NCT05278520', 'acronym': 'OASEQ', 'briefTitle': 'Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Studies on the Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis', 'orgStudyIdInfo': {'id': '2022OASEQ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OA cases', 'description': 'Fifty adult patients who have hip osteoarthritis.', 'interventionNames': ['Procedure: Total hip arthroplasty']}, {'label': 'RA cases', 'description': 'Forty adult patients who have rheumatoid arthritis in the hip joint.', 'interventionNames': ['Procedure: Total hip arthroplasty']}, {'label': 'Non-arthritic controls', 'description': 'Twenty adult patients who go through trauma-based emergency total hip arthroplasty and do not have arthritis.', 'interventionNames': ['Procedure: Total hip arthroplasty']}], 'interventions': [{'name': 'Total hip arthroplasty', 'type': 'PROCEDURE', 'description': 'Hip joint replacement surgery. Elective for RA and OA cases.', 'armGroupLabels': ['Non-arthritic controls', 'OA cases', 'RA cases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Turku', 'state': 'Southwest Finland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Finland', 'facility': 'PET-centre, University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Turku', 'state': 'Southwest Finland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Finland', 'facility': 'Turku Bioscience, University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Turku', 'state': 'Southwest Finland', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pjotr Sarantsin, MD', 'role': 'CONTACT', 'email': 'Pjotr.Sarantsin@tyks.fi'}, {'name': 'Pjotr Sarantsin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Espoo', 'state': 'Uusimaa', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Anna Vasara, MD, PhD', 'role': 'CONTACT', 'email': 'anna.vasara@hus.fi'}, {'name': 'Anna Vasara, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}], 'centralContacts': [{'name': 'Lea Mikkola, PhD', 'role': 'CONTACT', 'email': 'limikk@utu.fi', 'phone': '+358404143300'}], 'overallOfficials': [{'name': 'Lea Mikkola, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku Bioscience, University of Turku'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Hospital District of Helsinki and Uusimaa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lea Mikkola', 'investigatorAffiliation': 'University of Turku'}}}}