Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT00633516
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2008-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009506', 'term': 'Nevus'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013059', 'term': 'Spectrum Analysis, Raman'}], 'ancestors': [{'id': 'D012542', 'term': 'Scattering, Radiation'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2008-03-04', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure atypical moles and melanoma', 'timeFrame': '4 weeks', 'description': 'Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['moles', 'melanoma'], 'conditions': ['Skin Cancer']}, 'descriptionModule': {'briefSummary': 'The incidence of malignant melanoma has increased dramatically in recent decades. In 1930, the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500. This has been exponentially increasing over the years with the risk estimated to be 1 in 75 in 2000 . According to the American Cancer Society, approximately 59,580 new cases of melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected to die of the disease.', 'detailedDescription': 'The researcher ucan use special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. The imaging devices are, Modified Two Layer Diffuse Optical Spectroscopy,multi-spectral imaging, and Spatially Modulated Quantitative Spectroscopy can use to measure atypical moles and melanoma and correlate the results of the biopsy tissue histology.\n\nThe imaging devices can quantify melanin, oxy and deoxy hemoglobin concentration, water, lipid and reduced scattering coefficients and can compare results to histopathologic. Atypical moles and melanoma have a different optical profile based on physiological parameters compared to benign nevus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older.\n* Have atypical mole/s and melanoma\n\nExclusion Criteria:\n\n* Age less than 18 years old.\n* have NO atypical mole/s and melanoma'}, 'identificationModule': {'nctId': 'NCT00633516', 'briefTitle': 'A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters', 'orgStudyIdInfo': {'id': '20086099'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical tool', 'description': 'Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy', 'interventionNames': ['Device: Optical Spectroscopy']}], 'interventions': [{'name': 'Optical Spectroscopy', 'type': 'DEVICE', 'otherNames': ['Optical Spectroscopy imaging'], 'description': 'Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy', 'armGroupLabels': ['Medical tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Beckman Laser Medical clinic, UCI', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCIMC', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'David JB Hsiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute University of California Irvine'}, {'name': 'Bruce Tromberg, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beckman Laser Institute 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': 'David Hsiang, M.D., Division of Surgical Oncology', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}