Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-27 @ 12:19 PM
Study NCT ID:
NCT05877404
Status:
TERMINATED
Last Update Posted:
2024-04-19
First Post:
2023-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Practice Patterns Among Gynecologic Oncologists on Tumor Genetic Testing in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This was a national survey of physicians. Per the protocol, they were only allowed to be contacted twice and they received less surveys back than anticipated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of providers reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients', 'timeFrame': '4 months', 'description': "The primary outcome is to estimate the percentage of providers who report the use of different tumor testing strategies. Investigators will calculate the frequencies of responses to each testing strategy and then compare the percentage of physicians who choose different strategies, using a chi-square or Fisher's exact test."}], 'secondaryOutcomes': [{'measure': 'Frequency of providers using different strategies of informed consent in tumor genetic testing in endometrial cancer', 'timeFrame': '4 months', 'description': 'Investigators will calculate the number of frequencies of different tumor testing informed consent strategies among physicians.'}, {'measure': 'Number of providers reporting confidence in utilizing tumor genetic testing to guide treatment decisions', 'timeFrame': '4 months', 'description': 'Investigators will calculate the number of providers who are very confident, moderately confident, a little confident or not at all confident in their ability to explain tumor testing strategies and results.'}, {'measure': 'Number of providers who change their counseling or testing strategies for endometrial cancer', 'timeFrame': '4 months', 'description': "Investigators will compare the number of providers who have changed their counseling or testing strategy based on their familiarity with recent publications regarding immune-checkpoint inhibitors in advanced and recurrent endometrial cancer using a chi-square or Fisher's exact test."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetic testing'], 'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'In order to formulate strategies to improve adherence to best practice guidelines, as well as utilization of novel therapies, investigators must understand current practice patterns surrounding tumor genetic testing in endometrial cancer. The aim is to survey a representative sample of gynecologic oncologists who belong to the society of gynecologic oncology, via an email survey, to better understand current practices surrounding tumor genetic testing as well as determine if there have been any changes to practice since the publication of recent trials on the use of immune-checkpoint inhibitors in endometrial cancer.', 'detailedDescription': 'Primary Objective: Proportion of physicians reporting the use of different tumor genetic testing strategies among newly diagnosed endometrial cancer patients.\n\nSecondary Objectives:\n\n* Explore the use of informed consent in tumor genetic testing in endometrial cancer\n* Explore clinician confidence in utilizing tumor genetic testing to guide treatment decisions.\n* Explore the impact of recent publications regarding immunotherapy on the use of tumor genetic testing in endometrial cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Member of the Society of Gynecologic Oncology\n* Gynecologic Oncologist or Gynecologic Oncology Fellow-in-Training'}, 'identificationModule': {'nctId': 'NCT05877404', 'briefTitle': 'Practice Patterns Among Gynecologic Oncologists on Tumor Genetic Testing in Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Practice Patterns Among Gynecologic Oncologists on Tumor Genetic Testing in Endometrial Cancer', 'orgStudyIdInfo': {'id': 'IRB00097221'}, 'secondaryIdInfos': [{'id': 'WFBCCC 99323', 'type': 'OTHER', 'domain': 'Wake Forest Baptist Comprehensive Cancer Center'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}, {'id': 'NCI-2023-05554', 'type': 'OTHER', 'domain': 'CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gynecologic Oncologists', 'description': 'Gynecologic Oncologists and gynecologic oncology fellows-in-training from around the world, who are members of the Society of Gynecologic Oncology (SGO).', 'interventionNames': ['Other: Surveys']}], 'interventions': [{'name': 'Surveys', 'type': 'OTHER', 'description': 'Survey on practice patterns surrounding tumor genetic testing in endometrial cancer.', 'armGroupLabels': ['Gynecologic Oncologists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Kathryn Weaver, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest Baptist Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}