Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-20 @ 2:49 PM
Study NCT ID:
NCT04175067
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D014591', 'term': 'Uterine 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum blood samples for aech participant'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum native thiol level', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'serum native thiol level in μmol/L'}, {'measure': 'serum disulphide level', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'serum disulphide level in μmol/L'}, {'measure': 'serum total thiol level', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'serum total thiol level in μmol/L'}, {'measure': 'the disulphide/native thiol ratio', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'the disulphide/native thiol ratio X (100 )'}, {'measure': 'disulphide/total thiol ratio', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'disulphide/total thiol ratio X (100 )'}, {'measure': 'native thiol/total thiol ratio', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'native thiol/total thiol ratio X (100 )'}], 'secondaryOutcomes': [{'measure': 'total antioxidant capacity (TAC)', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'TAC in mmol trolox equivalent/L'}, {'measure': 'total oxidant capacity (TOC)', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'TOC in mmol H2O2 equivalent/L.'}, {'measure': 'Oxidative stress index (OSI)', 'timeFrame': 'preoperative in the morning or preprandial for healthy volunteers', 'description': 'OSI in mmol trolox/L.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early stage', 'thiol disulfide hemostasis', 'malignancy'], 'conditions': ['Endometrium Cancer', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate thiol-disulfide balance in early stage endometrium cancer patients.', 'detailedDescription': 'To date various oxidative stress paramaters were studied in patients with endometrial cancer, however dynamic thiol disulfide hemostasis has not been previously investigated.\n\nThe thiol-disulfide balance in the circulation will be measured by the automated system created by Erel \\& Neselioglu(1).\n\nReferences\n\n1- Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem 2014;47:326-32. doi:10.1016/j.clinbiochem.2014.09.026.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The preoperative diagnosis of Endometrium cancer was made histopathologically by endometrial biopsy. An experienced pathologist performed frozen section analysis according to the surgical staging scheme of the International Federation of Gynaecology and Obstetrics.', 'genderDescription': 'endometrium cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Histopathologically confirmed diagnosis of stage I endometrium cancer\n\nExclusion Criteria:\n\n* pulmonary disease\n* pulmonary hypertension\n* cardiac dysfunction\n* renal dysfunction\n* liver disease\n* chronic ishemia\n* systemic inflammation\n* concomitant malignancy\n* patients who use vitamin A,C or E (antioxidant vitamins)\n* patients who use smoke\n* patients who use drink alcohol\n* patients who use addictive for any drug'}, 'identificationModule': {'nctId': 'NCT04175067', 'briefTitle': 'Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'Assessment of Thiol Disulfide Balance in Early Stage Endometrium Cancer', 'orgStudyIdInfo': {'id': '09/08/2018-13-9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometrium cancer', 'description': 'stage I endometrium cancer n=57', 'interventionNames': ['Diagnostic Test: Disulphide(μmol/L)', 'Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)']}, {'label': 'Healthy controls', 'description': 'Healthy volunteers n=60', 'interventionNames': ['Diagnostic Test: Disulphide(μmol/L)', 'Diagnostic Test: Total Oxidant Capacity(μmolH2O2Equiv/L)']}], 'interventions': [{'name': 'Disulphide(μmol/L)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Native thiol (μmol/L)', 'Total thiol (μmol/L)', 'Nativethiol/totalthiol(%)', 'Disulfide/nativethiol(%)', 'Disulfide/totalthiol(%)'], 'description': 'Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry', 'armGroupLabels': ['Endometrium cancer', 'Healthy controls']}, {'name': 'Total Oxidant Capacity(μmolH2O2Equiv/L)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Total Antioxidant Capacity(mmolTroloxEquiv/L)', 'Oxidative stress Index (Arbitrary Unite)'], 'description': 'Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry', 'armGroupLabels': ['Endometrium cancer', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sıtkı Kocman University Faculty of Medicine', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Burak Sezgin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mugla Sıtkı Kocman University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Burak Sezgin', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}