Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,070
- 试验地点
- 4
- 主要终点
- Fluorescent Measurements of Cervix
研究概览
简要总结
RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninvasively detect cervical intraepithelial neoplasia and dysplasia.
PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.
详细描述
OBJECTIVES:
- Identify potential improvements in noninvasive methods of diagnosing dysplasia and neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy participants with a history of normal pap smears.
- Determine the reflection and fluorescence spectra of in vivo samples of the normal human cervix.
- Refine the detection of cervical lesions by fluorescence spectroscopy in these participants using improved classification of normal columnar tissue and non-neoplastic tissue with inflammation.
- Determine and validate the wavelength selections for spectroscopic diagnosis derived from in vitro measurements from these participants.
- Compare specific tissue sections from these participants with their excitation-emission matrices in order to identify the cell types contributing to the signal.
OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy*. The probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. Participants undergo biopsies of both sites.
NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
- •Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
排除标准
- •Pregnant individuals will be ineligible for this study.
结局指标
主要结局
Fluorescent Measurements of Cervix
时间窗: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.
Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.
次要结局
未报告次要终点