Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
研究概览
简要总结
The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix.
The specific aims of the study are:
- To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.
- To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.
- To analyze digital images to determine which types of optical information yield the most diagnostically useful data.
详细描述
If you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix.
VISUAL DETECTION OF PRECANCEROUS LESIONS:
Reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue.
STUDY PARTICIPATION:
You will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older who are referred to the University of Texas MD Anderson Cancer Center Colposcopy Clinic for colposcopy are eligible for this study.
- •Patients must sign an informed consent indicating awareness of the investigational nature of this study.
排除标准
- •Patients who are pregnant are not eligible for this study.
结局指标
主要结局
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
时间窗: 2 Year
次要结局
未报告次要终点