Optical Spectroscopy for Cutaneous Cancer

NCT02522793 | Completed

• 1 other identifier: Pro00058440
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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

Keywords

skin lesion

Outcome Measures

Primary Outcomes (1)

• spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue.

  Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis.

  1 day visit

Interventions

No intervention; this is an observational study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who present to the Duke or VA Dermatology or Otolaryngology clinics with a suspicious skin lesion that is in need of a biopsy.

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• Charles Woodard, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 13, 2015
• Study Start: May 1, 2016
• Primary Completion: February 3, 2017
• Study Completion: February 3, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-06

Locations

US (1)