Point-of-Care Ultraviolet Microscopy for Cervical Cancer Screening

NCT05899647 | Unknown

• 1 other identifier: STUDY00003019
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Screening; ultraviolet microscope; cervical dysplasia; Pap smear

Outcome Measures

Primary Outcomes (1)

• Cellular features

  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

Study Arms (1)

Enrolled Patients

EXPERIMENTAL

Consented patients who have had an additional Pap sample taken at their visit.

Diagnostic Test: Ultraviolet Microscopic Analysis

Interventions

Ultraviolet Microscopic Analysis DIAGNOSTIC_TEST

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.

Enrolled Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Steven J Dudick, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 12, 2023
• Study Start: November 27, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (1)