Optical Spectroscopy for Cutaneous Cancer
NCT02522793 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2017-07-11
Summary
1. Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner.
2. Study activities and population group: Competent adults with a clinically suspicious skin lesion who are undergoing a biopsy as part of their routine care. For those who agree to participate, the sterilized portable optical spectroscopic probe will be used to measure diffuse reflectance on the lesion of clinical interest.
3. Data analysis and risk/safety issues: The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis. A variety of correlative statistics will be explored to determine if there are relationships found that can justify a larger study
Conditions
- Suspicious Skin Lesion(s) Requiring a Biopsy
Interventions
- OTHER
-
No intervention; this is an observational study
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Charles Woodard, MD · Duke University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2017-02-03
- Completion
- 2017-02-03
Countries
- United States
Study Locations
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