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Point-of-Care Ultraviolet Microscopy for Cervical Cancer Screening

NCT05899647 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2023-11-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Steven J Dudick, MD · University of Arizona

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2024-07-31
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05899647 on ClinicalTrials.gov