Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-17 @ 6:13 PM
Study NCT ID:
NCT02579551
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2015-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate for 1 mm margins', 'timeFrame': 'Up to 3 years', 'description': 'The success rate for 1 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion.'}, {'measure': 'Success rate for 2 mm margins', 'timeFrame': 'Up to 3 years', 'description': 'The success rate for 2 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion.'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate after 3 years', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Basal Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://hospitals.jefferson.edu/', 'label': 'Thomas Jefferson University Hospital'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the effectiveness of narrow margins in patients with low-risk basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the area of normal tissue around a tumor taken out during surgery to make sure all of the cancer is removed. This clinical trial studies tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate. This may allow less normal tissue to be removed from patients and may be a less expensive surgery.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the success rate of narrow margin excisions of low-risk facial basal cell carcinoma (BCC).\n\nSECONDARY OBJECTIVES:\n\nI. To determine the narrowest excision margin for low-risk facial BCC that gives an acceptable (95%) cure rate over a 3 year follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Location\n\n 1. Area M (cheeks, forehead, scalp \\& neck) tumor size \\< 10 mm\n 2. Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \\& postauricular, temple \\& ear) tumor size \\< 6 mm\n2. Well-defined borders\n3. Primary BCC\n4. Patient is not immunosuppressed\n5. There has not been prior radiotherapy to the site\n6. Nodular subtype\n7. No perineural involvement-(no neurological deficits grossly) -\n\nExclusion Criteria:\n\n1. Location\n\n 1. Area M tumor size \\> or = to 10 mm\n 2. Area H tumor size \\> or = to 6 mm\n2. Poorly defined borders\n3. Recurrent BCC\n4. Patient is immunosuppressed\n5. There has been prior radiotherapy to the site -'}, 'identificationModule': {'nctId': 'NCT02579551', 'briefTitle': 'Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas', 'orgStudyIdInfo': {'id': '11D.479'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01624', 'type': 'REGISTRY', 'domain': 'NCI Trial Identification'}, {'id': 'JT 2143', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (surgical excision)', 'description': 'Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.', 'interventionNames': ['Procedure: Therapeutic Conventional Surgery']}], 'interventions': [{'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo surgical excision', 'armGroupLabels': ['Treatment (surgical excision)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson Univeristy', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jason Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}