Viewing Study NCT02638402


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Study NCT ID: NCT02638402
Status: UNKNOWN
Last Update Posted: 2016-05-13
First Post: 2015-12-20
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Expression of Altered Glycosyltransferases, Mucins, and RTKs in Human Ovarian and Endometrial Cancers
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'C536137', 'term': 'Medullary cystic kidney disease 1'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2015-12-20', 'studyFirstSubmitQcDate': '2015-12-20', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the Immunohistochemistry (IHC) expression', 'timeFrame': '5 years after patient received surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glycosylation', 'mucin', 'receptor tyrosin kinases', 'ovarian cancer', 'endometrial cancer'], 'conditions': ['Carcinogenesis', 'Ovarian Cancer', 'Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays.', 'detailedDescription': 'Glycosylation is a widely utilized chemical modification of proteins and lipids in mammalian cells during which saccharide units are covalently attached to the target structures and then sequentially elongated and branched - reactions facilitated by a large number of various glycosyltransferases. Alterations in this process have been associated with malignant transformation. To clarify the critical role of glycosyltransferases, altered Mucins (MUC), and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases (including β-1,4-Galactosyltransferase 1 (B4GALT1), β-1,4-Galactosyltransferase 3 (B4GALT3), β-1,4-N-Acetyl-Galactosaminyl Transferase 3 (B4GALNT3), Polypeptide N-Acetylgalactosaminyltransferase 2 (GALNT2), Polypeptide N-Acetylgalactosaminyltransferase 6 (GALNT6), β1,4-N-acetylglucosaminyltransferase III (GlcNAcT-III), β1,4-N-acetylglucosaminyltransferase V (GlcNAcT-V), and Glycoprotein-N-Acetylgalactosamine 3-Beta-Galactosyltransferase 1 (C1GALT1), Mucins (including MUC1, MUC3, MUC15, and MUC20) and receptor tyrosin kinases (RTKs) family (including epidermal growth factor receptor (EGFR), Src, VEGFR, and c-Met) in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays, and compare them with clinicopathologic factors including outcome of the patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital\n\nExclusion Criteria:\n\n* Recurrence or non-operable patients'}, 'identificationModule': {'nctId': 'NCT02638402', 'briefTitle': 'Expression of Altered Glycosyltransferases, Mucins, and RTKs in Human Ovarian and Endometrial Cancers', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Expression of Altered Glycosyltransferases, Mucins, and RTKs in Human Ovarian and Endometrial Cancers', 'orgStudyIdInfo': {'id': '201405068RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stage I, II, III, IV ovarian cancer', 'description': 'Stage I, II, III, IV ovarian cancer receive treatment in National Taiwan University Hospital'}, {'label': 'Stage I, II, III, IV endometrial cancer', 'description': 'Stage I, II, III, IV endometrial cancer receive treatment in National Taiwan University Hospital'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chi-Hau Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chihau@ntuh.gov.tw', 'phone': '+886-972651980'}], 'overallOfficials': [{'name': 'Chi-Hau Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}