Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT03765905
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2018-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2018-06-22', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum SCUBE 1', 'timeFrame': '01.01.2017-31.12.2017', 'description': 'Serum scube1 in microgram'}, {'measure': 'Serum SCUBE 2', 'timeFrame': '01.01.2017-31.12.2017', 'description': 'Serum scube2 in microgram'}, {'measure': 'Serum SCUBE 3', 'timeFrame': '01.01.2017-31.12.2017', 'description': 'Serum scube3 in microgram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'SCUBE', 'Cardiovascular disease'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index', 'detailedDescription': 'The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index.\n\nThis will be a prospective clinical laboratory study,It will include women with PCOS diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be included in the study group, which will be included in the survey after being approved for participation in the survey from field trials. Forty patients who will not have any complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control group but who had no PCOS o rany other systemic problems and will be similar in terms of age group and body mass index will be included in the study after being approved for participation in the study. From the study and control group, 5 mL of blood will be taken from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1, SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '40 women diagnosed with PCOS between the ages of 18-35', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Clinical diagnosis of PCOS\n* 18-35 years old\n\nExclusion Criteria\n\n* Endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease and congenital adrenal hyperplasia), systemic disease (eg asthma), collagen disorder, hypercholesterolemia, sickle cell anemia or neoplasm,\n* Coronary artery disease , angina or myocardial infarction, or any known vascular, infectious, or inflammatory disease, including hypertension, coronary arterioscitis, and electrocardiographic changes;\n* Use of any medication (e.g., insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, corticosteroids and gonadotropin releasing hormone agonists and antagonists) within the previous 3 months;\n* Abnormal serum albumin concentration (normal concentration, 30-55 g / l),\n* Abnormal troponin I concentration,\n* Present smoker,\n* Abnormal renal, hepatic and thyroid function test results;\n* Refusing to participate in the work."}, 'identificationModule': {'nctId': 'NCT03765905', 'briefTitle': 'Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,', 'orgStudyIdInfo': {'id': 'Karadeniz Technical University'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCOS diagnosis area', 'description': 'The study group consisted of 40 reproductive age women between 18th and 35th years old women who were PCOS diagnosis (according to the 2003 Rotherdam criteria)', 'interventionNames': ['Diagnostic Test: study']}, {'label': 'PCOS is not diagnosed', 'description': 'Forty patients who did not have any complaints between the ages of 18-35 who applied to the gynecology policlinic as a control group but who had no PCOS orany other systemic problems and were similar in terms of age group and body mass index were included in the study after being approved for participation in the study', 'interventionNames': ['Diagnostic Test: study']}], 'interventions': [{'name': 'study', 'type': 'DIAGNOSTIC_TEST', 'description': 'Scube-1 scube-2 scube-3', 'armGroupLabels': ['PCOS diagnosis area', 'PCOS is not diagnosed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61000', 'city': 'Trabzon', 'state': 'Ortahisar', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University Faculty of Medicine', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Süleyman Güven, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karadeniz TU Medicine Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Suleyman Guven', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}