Point of Care Ultraviolet Microscopy as a Novel Screening Method for Cervical Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Cellular features
研究概览
简要总结
This study aims to determine the image features of cervical cells, as measured via ultraviolet microscopy, that would constitute a positive screening and a negative screening result for cervical dysplasia, a precursor to cervical cancer, as measured against liquid-based Papanicolaou testing.
详细描述
The study population will consist of patients presenting to one of the three outpatient gynecology clinics within the Banner University Medical Center system for either a routine or follow up cervical cancer screening. Eligible subjects will be informed of the study and asked to consent to participate in accordance with standard informed consent protocol.
The subject will undergo a Papanicolaou screening test, using both a spatula and a cytobrush and collected in a Thinprep specimen container according to the manufacturer's instructions. This specimen will be used for standard-of-care cytology. A second specimen will then be obtained in an identical fashion, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy.
The second specimen will be taken from the clinic for processing in preparation for UV microscopy. A sample of the specimen will be smeared onto a UV slide and images taken. The UV images will be then analyzed to extract the following features for determining the stage of cervical lesion:
- Cellularity: The density of cells in the sample. A high cellularity indicates an abnormal growth of cells.
- Nuclear features: The size and shape of the nuclei in the cells. Abnormal nuclear features, such as enlarged nuclei or irregular chromatin distribution, can indicate the presence of a cervical lesion.
- Cytoplasmic features: The appearance of the cytoplasm in the cells. Abnormal cytoplasmic features, such as vacuolation or hyperchromasia, can indicate the presence of a cervical lesion.
- Cellular architecture: The organization and arrangement of the cells in the sample. Abnormal cellular architecture, such as loss of polarity or crowding of cells, can indicate the presence of a cervical lesion.
A second subject arm will consist of patients presenting to colposcopy clinic for colposcopy due to LSIL or HSIL findings on a screening Pap test. Subjects with test results of ASCUS or ASC-H will be excluded. A cervical cytology specimen will be taken from these subjects using both a spatula and a cytobrush, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy in a manner identical to the second specimen processing described above. Participants will then undergo colposcopy according to the standard of care based upon their prior cytology results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients presenting for cervical cancer screening.
- •Patients presenting for follow-up for positive cervical cancer screening.
排除标准
- •Patients who do not, or no longer, require cervical cancer screening
结局指标
主要结局
Cellular features
时间窗: One year
The extracted features from the UV microscopic analysis will be compared with the results from the standard-of-care cytology. Gaussian distributions will be plotted for each feature, with a separate distribution plotted for patients who screen positive and who screen negative based on standard-of-care cytology results. Combinations of UV microscopy features compared to the standard-of-care cytology results; and, if applicable, their colposcopy results; will be recorded and plotted as well. Areas of overlap between these distributions will be used to select an appropriate threshold value, with a target false negative rate of 14% or better
次要结局
未报告次要终点
研究者
Steven Dudick
Clinical Assistant Professor
University of Arizona