Point-of-Care Ultraviolet Microscopy for Cervical Cancer Screening

November 27, 2023 updated by: Steven Dudick, University of Arizona

Point of Care Ultraviolet Microscopy as a Novel Screening Method for Cervical Dysplasia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Banner University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients presenting for cervical cancer screening.
  • Patients presenting for follow-up for positive cervical cancer screening.

Exclusion Criteria:

  • Patients who do not, or no longer, require cervical cancer screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enrolled Patients
Consented patients who have had an additional Pap sample taken at their visit.
Diagnostic test: Ultraviolet Microscopic Analysis
Data to be collected from subjects at the time of their clinical visit; or upon chart review by the research team; will include demographic information, whether the subject is presenting for a routine screen or for a follow-up, and the subject's most recent cervical cytology result. Data to be collected from the standard-of-care cytology will include the cytologic diagnosis and the presence or absence of human papilloma virus (HPV), if applicable based on the subject's age. The Pap results of each subject will be reviewed and classified as "screen negative" (NIL), "screen positive" (LSIL, HSIL), or "indeterminate" (ASCUS, ASC-H). Subjects with a positive screen, or an indeterminate result, who undergo colposcopy will have their colposcopy results recorded as well. The UV microscopy imaging features will be coded and collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular features
Time Frame: 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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Steven J Dudick, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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