Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-04-14 @ 2:57 AM
Study NCT ID:
NCT02534558
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2015-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathomechanism of MicroRNA-29 in Shoulder Stiffness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-05', 'studyFirstSubmitDate': '2015-04-13', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The microRNA expression, mRNA expression as a measure', 'timeFrame': '48hr', 'description': "Differences among incidence, microRNA expression, mRNA expression of shoulder stiffness are analyzed using non-parametric student's t-test. P value of \\< 0.05 is considered statistically significant."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MicroRNA-29', 'shoulder stiffness', 'mir-29a'], 'conditions': ['Stiffness of Shoulder, Not Elsewhere Classified']}, 'descriptionModule': {'briefSummary': 'The team integrates experimental analyses of clinical and basic medicine and transgenic mice models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue homeostasis that alleviates tissue stiffness and maintains function.', 'detailedDescription': 'Aims of first: The team will evaluate the associations among the mR-29a, miR-29b, miR-29c expression in subacromial bursa and subacromial fluid, incidence of shoulder stiffness, Constant scores, and VAS.\n\nAims of second: The team will isolate primary myofibroblast from subacromial bursa tissue as in vitro models and investigate the molecular events in the IL-1β modulation of miR-29a expression and the molecular mechanism underlying miR-29a inhibition of fibrotic matrix accumulation and apoptotic reactions in myofibroblast cultures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 to 80 years\n* receiving surgery for open acromioplasty\n\nExclusion Criteria:\n\n* shoulder disorders caused by traumatic fracture\n* previous surgery\n* osteoarthritis\n* malignant disorders\n* hepatic disorders\n* renal disorders'}, 'identificationModule': {'nctId': 'NCT02534558', 'briefTitle': 'Pathomechanism of MicroRNA-29 in Shoulder Stiffness', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Pathomechanism of MicroRNA-29 in Shoulder Stiffness', 'orgStudyIdInfo': {'id': 'IRB 102-5462B'}, 'secondaryIdInfos': [{'id': 'ChangGungMH', 'type': 'REGISTRY', 'domain': 'ChangGungMH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'miR-29a precursor oligonucleotide', 'description': 'Effects of IL-1β, miR-29a precursor oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified', 'interventionNames': ['Biological: miR 29a']}, {'type': 'EXPERIMENTAL', 'label': 'miR-29a antisense oligonucleotide', 'description': 'Effects of IL-1β, miR-29a antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified', 'interventionNames': ['Biological: miR 29a']}], 'interventions': [{'name': 'miR 29a', 'type': 'BIOLOGICAL', 'description': 'Effects of IL-1β, miR-29a precursor or antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified', 'armGroupLabels': ['miR-29a antisense oligonucleotide', 'miR-29a precursor oligonucleotide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jih-Yang Ko, MD', 'role': 'CONTACT', 'email': 'kojy@cgmh.org.tw', 'phone': '886-7-731-7123', 'phoneExt': '8003'}, {'name': 'Jih-Yang Ko, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Jih-Yang Ko, MD', 'role': 'CONTACT', 'email': 'kojy@cgmh.org.tw', 'phone': '886-7-731-7123', 'phoneExt': '8003'}], 'overallOfficials': [{'name': 'Yang-Jih Ko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}