Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-03 @ 10:06 AM
Study NCT ID:
NCT02331550
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2015-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-25', 'studyFirstSubmitDate': '2015-01-03', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that progressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that regressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low-Grade Squamous Intraepithelial Lesions'], 'conditions': ['LSIL, Low-Grade Squamous Intraepithelial Lesions']}, 'descriptionModule': {'briefSummary': 'To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Low-Grade Squamous Intraepithelial Lesion by cervical cytology.\n* Positive Biopsy for Low-Grade Squamous Intraepithelial Lesion after colposcopy.\n\nExclusion Criteria:\n\n* Serological detection of human immunodeficiency virus (HIV).'}, 'identificationModule': {'nctId': 'NCT02331550', 'briefTitle': 'Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.', 'orgStudyIdInfo': {'id': 'MHST2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expectant treatment', 'description': 'Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with observation and evaluation at 6 and 12 months after diagnosis.', 'interventionNames': ['Procedure: Expectant management']}, {'type': 'EXPERIMENTAL', 'label': 'Ablative treatment', 'description': 'Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with an ablative treatment and evaluated at 6 and 12 months after diagnosis.', 'interventionNames': ['Procedure: Ablative treatment']}], 'interventions': [{'name': 'Ablative treatment', 'type': 'PROCEDURE', 'description': 'Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.', 'armGroupLabels': ['Ablative treatment']}, {'name': 'Expectant management', 'type': 'PROCEDURE', 'description': 'Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions were managed with observation and evaluation at 6 and 12 months after diagnosis.', 'armGroupLabels': ['Expectant treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Saint Thomas H', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Osvaldo Reyes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Hospital, Panama'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Research', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}