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临床试验/NCT02704039
NCT02704039已完成不适用

Multimodal Spectroscopy (MMS) for in Vivo Noninvasive Assessment of Skin

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
239
试验地点
1
主要终点
Aim 2: Perform clinical assessment of MMS for skin malignancy

研究概览

简要总结

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.

详细描述

To develop a biophysical model the investigators will recruit patients based on their known histopathology diagnoses, from each of 6 skin-cancer categories: basal cell carcinoma, squamous cell carcinoma, melanoma, atypical nevus, actinic keratosis, and benign skin. Patients with non-cancer diagnosis such as psoriasis, eczema / dermatitis, lichen planus or lupus will also be recruited. Recruitment will include 5 patients from each of these categories, giving a total of 20 patients. Measurements for the biophysical models are conducted on skin tissues that have been excised from the patients. Furthermore, these skin tissues are excised tissues that under standard screening procedure will be biopsied by the dermatologist. Therefore, patients are not undergoing extra & unnecessary biopsies, and will not be exposed to any risk involved with the microspectroscopy measurements.

To determine the diagnostic accuracy of MMS, MMS data will be collected from six clinical groups, each with a preoperative diagnosis: 1) malignant melanoma (MM), 2) basal cell carcinoma (BCC), 3) squamous cell carcinoma (SCC), 4) pre-cancerous lesions (AK), 5) benign or atypical nevi, or 6) other lesions or conditions (rare skin cancers such as merkel cell carcinoma, and inflammatory conditions such as psoriasis). The aim is to collect MMS data from a minimum of 240 patients (40 patients for each of the 6 groups), which will be split to training and validation datasets. Since several biopsies are required to diagnose a single skin cancer, it is anticipated that the actual number of pre-cancerous, benign and inflammatory lesions sampled will be much higher than our target total of 240, to be around 300. We will also collect data from non-skin cancer skin conditions: 1) psoriasis, 2) eczema / dermatitis, 3) lichen planus and 4) lupus. For the non-skin-cancer part of the study, we will enroll 20 patients from each of the categories, with a total target of 80 patients.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing examination of skin
  • Male or Female 18 years and older
  • 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.
  • Signed consent form

排除标准

  • Patients with skin lesions in difficult to measure locations
  • Patients that do not sign the consent forms

结局指标

主要结局

Aim 2: Perform clinical assessment of MMS for skin malignancy

时间窗: 1 year

develop a biophysically-orientated model of human skin using Raman spectroscopy, with the goal of obtaining tissue microenvironment structural and chemical information.

Aim 1: Develop biophysical model for Raman spectroscopy

时间窗: 6 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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