Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-23 @ 1:55 AM
Study NCT ID:
NCT01961102
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial 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': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}, {'id': 'D003475', 'term': 'Curettage'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-07', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A negative predictive value of 99 %', 'timeFrame': 'Intraoperative', 'description': 'To get in combination of hysteroscopy and rapid section of the endometrial curettement a negative predictive value of 99% as well as a positive predictive value of 100%.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postmenopausal bleeding', 'postmenopausal hyperplasia', 'endometrial cancer', 'atypical hyperplasia', 'curettage', 'intraoperative rapid section'], 'conditions': ['Endometrial Cancer', 'Atypical Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '28265757', 'type': 'DERIVED', 'citation': 'Hefler-Frischmuth K, Hirtl-Goergl E, Unterrichter V, Lafleur J, Brunnmayr-Petkin G, Moinfar F, Hefler L. One-stop clinical assessment of risk for endometrial hyperplasia (OSCAR-Endo): a fast-track protocol for evaluating endometrial pathologies. Arch Gynecol Obstet. 2017 Apr;295(4):959-964. doi: 10.1007/s00404-017-4326-8. Epub 2017 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.', 'detailedDescription': 'If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign.\n\nIn case of a hysteroscopical benign result the patient will be informed about the result after the operation.\n\nIn case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal status (more than 1 year of last menopausal bleeding)\n* Postmenopausal vaginal bleeding\n* Asymptomatic postmenopausal endometrial hyperplasia\n* Understanding of the german language\n* Signature and consent of the patient\n\nExclusion Criteria:\n\n* Not able to understand and participate in the study\n* Premenopausal status\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT01961102', 'briefTitle': 'OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Krankenhaus Barmherzige Schwestern Linz'}, 'officialTitle': 'Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer', 'orgStudyIdInfo': {'id': 'BHS-Gyn1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hysteroscopy/curettage in case of suspicious aspect will be done a rapid section', 'type': 'PROCEDURE', 'otherNames': ['OSCAR Endo Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Department of Gynaecology, Barmherzige Schwestern', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krankenhaus Barmherzige Schwestern Linz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}