Polarized Reflectance Spectroscopy for Oral Lesions (PolProbe)
Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions
In this study the investigators are conducting research to determine whether a new optical device using polarization reflectance spectroscopy can help doctors or dentists identify abnormalities in the mouth that require follow-up. To establish this, measurements are needed from a large number of individuals with different abnormalities in their mouth.
The investigators believe the proposed approach has potential to improve and enable mass screening for precancerous and early cancers of the oral cavity by improving the predictive value of oral cavity exams, particularly for less experienced practitioners.
The information from this study will be compared to results from the pathology report of the tissue taken from your mouth.
Hypothesis:
- Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and reactive oral lesions.
- Polarized reflectance spectroscopy can capture low-grade oral lesions that have characteristics associated with a high risk of progression to cancer.
研究概览
详细说明
The clinician will place a fiber-optic probe designed to measure the polarized reflectance spectra over the visible optical region on a site of interest in the subject's mouth, including lesional mucosa, normal adjacent and contralateral mucosa. The site for placement of the probe will be determined by the examiner, an experienced Oral Pathologist. The probe examination will take no more than 15 minutes in addition to the subject's appointment time for their routine visits.
A 4um unstained tissue section from surgery or biopsy, part of their scheduled care, will be requested for quantitative histological analysis. The morphometric parameters obtained from polarized reflectance measurements will be compared with the histology and quantitative pathology (nuclear phenotype score) from the tissue sections from the lesion. The collected spectra data from normal looking areas from adjacent normal looking mucosa and contralateral mucosa will be used to determine patient to patient variation in the polarized reflectance of oral mucosa.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V5Z 1L3
- British Columbia Cancer Agency - Vancouver Centre
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- You attend the Dental Department at the British Columbia Cancer Agency
- You have an abnormal lesion in the mouth
- You fully understand the study and give your informed consent to participate as demonstrated by signing this consent form
Exclusion Criteria:
- You are under the age of 18 years.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Polarized probe measurement.
All patients belong under this arm as all will be measured by the polarized probe and the data will be compared to the biopsy site's pathology results.
|
Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue.
大体时间：2 years
|
The goals of the statistical analysis will be to determine an appropriate model for predicting whether the lesion is normal or abnormal (dysplasia or carcinoma) based on spectroscopic characteristics.
The investigators will estimate sensitivity and specificity of the predictions made by the model and compare this to sensitivity and specificity of standard white light clinical examination currently used in clinical practice.
|
2 years
|
合作者和调查者
调查人员
- 首席研究员：Catherine Poh, M.D. Ph.D、British Columbia Cancer Agency
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.