Skin Cancer Clinical Trial
Official title:
Multimodal Spectroscopy (MMS) for in Vivo Noninvasive Assessment of Skin
NCT number | NCT02704039 |
Other study ID # | 2013-07-0008 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | December 2018 |
Verified date | March 2019 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this research program is to develop a simple, noninvasive diagnostic device for assessing skin pathology without the need for a biopsy. The device being studied is a single system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250 patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for diagnosing skin malignancy.
Status | Completed |
Enrollment | 239 |
Est. completion date | December 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients undergoing examination of skin 2. Male or Female 18 years and older 3. Patients with lesion(s) including one of the following: BCC, SCC, pre-cancerous, pigmented lesion, benign lesions, OR suspected diagnosis of psoriasis, eczema, dermatitis, lichen planus and/or lupus. 4. Signed consent form Exclusion Criteria: 1. Patients with skin lesions in difficult to measure locations 2. Patients that do not sign the consent forms |
Country | Name | City | State |
---|---|---|---|
United States | Seton Dermatology Clinics | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | Cancer Prevention Research Institute of Texas, Seton Healthcare Family |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aim 1: Develop biophysical model for Raman spectroscopy | use of a new technique of biophysical modeling to analyze the Raman spectra. At the core of the technique is the measurement of a set of "basis spectra" which are fit to the data using ordinary least-squares. | 6 months | |
Primary | Aim 2: Perform clinical assessment of MMS for skin malignancy | develop a biophysically-orientated model of human skin using Raman spectroscopy, with the goal of obtaining tissue microenvironment structural and chemical information. | 1 year |
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