Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-23 @ 11:36 AM
Study NCT ID:
NCT00540566
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2007-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D004416', 'term': 'Dysplastic Nevus Syndrome'}, {'id': 'D017492', 'term': 'Keratosis, Seborrheic'}, {'id': 'D010001', 'term': 'Osteitis Deformans'}, {'id': 'D018219', 'term': 'Histiocytoma, Benign Fibrous'}, {'id': 'D012514', 'term': 'Sarcoma, Kaposi'}, {'id': 'D019339', 'term': 'Port-Wine Stain'}, {'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D009506', 'term': 'Nevus'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D051642', 'term': 'Histiocytoma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2007-10-04', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'normal skin', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Melanoma', 'Merkel Cell Carcinoma', 'Basal Cell Carcinoma', 'Squamous Cell Carcinoma', 'Atypical Nevi', 'Congenital Nevi', 'Seborrheic Keratosis', "Paget's Disease", 'Dermatofibroma', "Kaposi's Sarcoma", 'Port Wine Stain', 'Hemangioma', 'Tattoos', 'Scleroderma', 'Burns']}, 'descriptionModule': {'briefSummary': 'This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.', 'detailedDescription': 'The Optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic, community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age \\> 18 years\n\nExclusion Criteria:\n\n* current participation in any other investigational drug evaluation\n* inability to understand and carry out instructions'}, 'identificationModule': {'nctId': 'NCT00540566', 'briefTitle': 'Optical Biopsy of Human Skin in Conjunction With Laser Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Optical Biopsy of Human Skin in Conjunction With Laser Treatment', 'orgStudyIdInfo': {'id': '1996200'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Optical Biopsy', 'description': 'Optical Biopsy imaging', 'interventionNames': ['Device: Optical Biopsy imaging']}], 'interventions': [{'name': 'Optical Biopsy imaging', 'type': 'DEVICE', 'description': 'Optical Biopsy imaging', 'armGroupLabels': ['Optical Biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Beckman Laser Institute, Unversity of California Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'John S Nelson, M.D,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institue, University of California Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beckman Laser Institute University of California Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}