Point-of-Care Ultraviolet Microscopy for Cervical Cancer Screening
- Conditions
- Cervical Cancer
- Interventions
- Diagnostic Test: Ultraviolet Microscopic Analysis
- Registration Number
- NCT05899647
- Lead Sponsor
- University of Arizona
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 232
- Patients presenting for cervical cancer screening.
- Patients presenting for follow-up for positive cervical cancer screening.
- Patients who do not, or no longer, require cervical cancer screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enrolled Patients Ultraviolet Microscopic Analysis Consented patients who have had an additional Pap sample taken at their visit.
- Primary Outcome Measures
Name Time Method Cellular features 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Banner University Medical Center
🇺🇸Tucson, Arizona, United States