Optical Spectroscopy for Cutaneous Cancer

Completed

Conditions studied: Suspicious Skin Lesion(s) Requiring a Biopsy

In brief

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

Key facts

Study ID

NCT02522793

Run by

Duke University

People needed

20

Starts

2016-05-01

Expected to finish

2017-02-03

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with at least one clinically suspicious skin lesion warranting a biopsy as part of routine care, in the outpatient clinic setting.
• Patients with previous histologically confirmed malignancy such as basal cell carcinoma or squamous cell carcinoma are eligible; however this is not required for enrollment.
• The suspicious skin lesion(s) is accessible to optical probe measurements. If patient has previous histologically confirmed malignancy of the skin, then the primary tumor site must be accessible to optical probe measurements
• Patient is able to provide written informed consent
• Patient is >18 years of age

You may not qualify if…

• < 18 years of age
• Unable to provide written informed consent

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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