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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 4, 2008 | ||||
| Last Updated Date | March 13, 2009 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
establish the variance of optical measurements in human pigmented lesions (benign and malignant). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00633516 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Pilot Study to Evaluate Optical Spectroscopy and SIAscopy of Pigmented Skin Lesions | ||||
| Official Title ICMJE | A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy and SIAscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters | ||||
| Brief Summary | The purpose of this study is to evaluate the physiological correlates of two imaging devices (1)Modified Two Layer Diffuse Optical Spectroscopy (MTL DOS ) and (2)SIAscopy in the evaluation of atypical moles and melanoma. A typical moles and melanoma will have a different optical profile based on physiological parameters compared to benign nevus. The first measured is to determine the hardware variability. From this optical data, a "correction" curve will be developed and this will be applied to all subsequent optical measurements. |
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| Detailed Description | The researcher using 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. Specifically,to compare malignant vs. benign lesions. The skin lesion will be exam and diagnose by the physician. The picture will be obtain by the technician use these two devices before and after the treatment of the lesion. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case Control, Prospective | ||||
| Condition ICMJE | Skin Cancer | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | February 2010 | ||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00633516 | ||||
| Responsible Party | David Hsiang, MD, Lead Researcher, Beckman Laser Institute, UCI | ||||
| Study ID Numbers ICMJE | RR-01192-29, LAMMP WIFI, LAMMP DOS | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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