Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00462969
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2007-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cytologic Analysis of Distention Media as a Screening Test for Endometrial 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2007-04-17', 'studyFirstSubmitQcDate': '2007-04-18', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytology results', 'timeFrame': 'At completion of enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endometrial cancer', 'Sonohysterography'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '23881100', 'type': 'RESULT', 'citation': 'Guralp O, Sheridan SM, Harter J, Hinshaw JL, Seo S, Hartenbach EM, Lindheim S, Stewart S, Kushner DM. A new diagnostic test for endometrial cancer?: Cytology analysis of sonohysterography distention media. Int J Gynecol Cancer. 2013 Sep;23(7):1252-7. doi: 10.1097/IGC.0b013e31829fe8f6.'}], 'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.', 'detailedDescription': 'Participants will have a sonohysterography (SHG) performed. Fluid will be collected after instillation of 5mls of saline and again after an adequate SHG is performed. A pathologist will review this fluid to see is cancer cells are present.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed early-stage endometrial cancer\n\nExclusion Criteria:\n\n* Recurrent or persistent endometrial cancer\n* Evidence of distant metastases'}, 'identificationModule': {'nctId': 'NCT00462969', 'briefTitle': 'Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer', 'orgStudyIdInfo': {'id': 'CC06701'}, 'secondaryIdInfos': [{'id': 'H-2006-0333', 'type': 'OTHER', 'domain': 'Health Sciences Institutional Review Board'}, {'id': 'NCI-2014-01355', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}, {'id': 'A532820', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\OBSTET & GYNECOL\\ONC', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'P30CA014520', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014520', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'pre-surgical SHG', 'interventionNames': ['Procedure: Sonohysterography']}], 'interventions': [{'name': 'Sonohysterography', 'type': 'PROCEDURE', 'description': 'Sonohysterography', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '553792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'David M Kushner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Obstetricians and Gynecologists', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}