Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-27 @ 12:25 PM
Study NCT ID:
NCT04955535
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening of Specific Genes for Pigmented Villous Nodular Synovitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013586', 'term': 'Synovitis, Pigmented Villonodular'}], 'ancestors': [{'id': 'D000070779', 'term': 'Giant Cell Tumor of Tendon Sheath'}, {'id': 'D005870', 'term': 'Giant Cell Tumors'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013585', 'term': 'Synovitis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of scale score between immunohistochemistry positive group and negative group', 'timeFrame': 'One week after surgery', 'description': 'Difference of Visual Analog Score for pain between CSF-1 immunohistochemistry positive group and negative group'}, {'measure': 'Difference of Visual Analog Score for pain between TNF-α immunohistochemistry positive group and negative group', 'timeFrame': 'One week after surgery', 'description': 'Difference of Visual Analog Score for pain between TNF-α immunohistochemistry positive group and negative group'}, {'measure': 'Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group', 'timeFrame': 'One week after surgery', 'description': 'Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group'}, {'measure': 'Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group', 'timeFrame': 'One week after surgery', 'description': 'Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group'}, {'measure': 'Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group', 'timeFrame': 'One week after surgery', 'description': 'Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group'}, {'measure': 'Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group', 'timeFrame': 'One week after surgery', 'description': 'Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group'}], 'secondaryOutcomes': [{'measure': 'Correlation between basic demographic characteristics and scale scores', 'timeFrame': 'One week after surgery', 'description': 'Correlation between age, gender and scale score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pigmented Villonodular Synovitis']}, 'descriptionModule': {'briefSummary': "This study retrospectively analyzed the history of present illness of PVNS patients in our hospital. The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions. Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.", 'detailedDescription': "This study retrospectively analyzed the symptoms, time of onset, injury history, laboratory examinations, imaging examinations, and intraoperative conditions of PVNS patients in our hospital. The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions (VAS score, SF-36 score). Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with "pigmented villonodular synovitis" and "giant cell tumor of tendon sheath"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of pigmented villonodular synovitis.\n2. Clinical diagnosis of giant cell tumor of tendon sheath\n\nExclusion Criteria:\n\n1. No surgical treatment.\n2. There were no pathological specimens during the operation.\n3. The age of the patient is less than 18 years old or more than 60 years old.\n4. The operation record shows nodular type.'}, 'identificationModule': {'nctId': 'NCT04955535', 'briefTitle': 'Screening of Specific Genes for Pigmented Villous Nodular Synovitis', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Screening of Specific Genes for Pigmented Villous Nodular Synovitis', 'orgStudyIdInfo': {'id': 'M201947901'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Arthroscopic synovectomy', 'type': 'PROCEDURE', 'description': 'Arthroscopic synovectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yingfang Ao, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Yniversity Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}