Optical Spectroscopy for Cutaneous Cancer

Non-Invasive Optical Spectroscopy for Identification of Cutaneous Cancer

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

Study Overview

• Status: Completed
• Conditions: Suspicious Skin Lesion(s) Requiring a Biopsy
• Intervention / Treatment: Other: No intervention; this is an observational study

Detailed Description

This is a pilot study to determine the optical spectroscopy characteristics of tumor in patients with cutaneous malignancies. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with numerous suspicious skin lesions who would require multiple biopsies.

Further spectroscopy measurements of the tumor site and adjacent normal tissue during therapy (chemoradiotherapy or radiotherapy) may provide useful information pertinent to tumor physiology and therapeutic effectiveness.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Charles Woodard, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): February 3, 2017
• Study Completion (Actual): February 3, 2017

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: skin lesion
• Other Study ID Numbers: Pro00058440