Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT03788850
Status:
COMPLETED
Last Update Posted:
2020-08-27
First Post:
2018-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Associated With Residual Disease In The Central Cone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify the clinical and pathologic factors associated with residual disease', 'timeFrame': '1month', 'description': 'Whit the variables identified as factors associated with the residual disease develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['residual disease', 'central cone', 'predictive model'], 'conditions': ['Cervical Intraepithelial Neoplasia']}, 'descriptionModule': {'briefSummary': 'Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies have shown that excising a central cone reduces the rate of positive endocervical margins. The purpose of this study is to identify clinicopathological factors associated with residual disease in the central cone and to develop a predictive model to better determine which patients may require this additional procedure.', 'detailedDescription': 'This study pretends to create a retrospective database including all patient who underwent a loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial neoplasia and create a a predictive model for top-hat resection in patients with high grade CIN'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent a cervical cone procedure at the Dysplasia Clinic of the Instituto Nacional de Cancerologia in Mexico City', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent a loop electrosurgical excision procedure (LEEP)\n\nExclusion Criteria:\n\n* a diagnosis of micro-invasion or nonsquamous histology\n* less than six months of follow-up\n* incomplete information in their clinical charts.'}, 'identificationModule': {'nctId': 'NCT03788850', 'acronym': 'FARDCC', 'briefTitle': 'Factors Associated With Residual Disease In The Central Cone', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Cancerología'}, 'officialTitle': 'Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model', 'orgStudyIdInfo': {'id': '12102018INC'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cancerología', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of clinical trial departament', 'investigatorFullName': 'David Cantu', 'investigatorAffiliation': 'National Institute of Cancerología'}}}}