Brief Summary

The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for early_phase_1

Timeline

Completed

Started Sep 2015

Longer than P75 for early_phase_1

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.6 years study duration

First Submitted

Initial submission to the registry

April 15, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed

5 months until next milestone

Study Start

First participant enrolled

September 23, 2015

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2021

Completed

Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

5.6 years

First QC Date

April 15, 2015

Last Update Submit

May 26, 2021

Conditions

Cervical Cancer

Keywords

Cervical CancerCervical DysplasiaAbnormal Pap testPositive human papillomavirus testHPVVisual inspection with acetic acidVIAColposcopyProflavineAcetic acidHigh-Resolution MicroendoscopyHRMEPhone call

Outcome Measures

Primary Outcomes (1)

Concordance Between the Diagnosis Using HRME Imaging and the Most Severe Histologic Diagnosis ( Concordance rate monitored using method described by Thall et al. (1995))
To evaluate the performance of HRME imaging compared with existing diagnostic techniques including colposcopy and visual inspection with acetic acid (VIA), a successful outcome is defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis. That is, researchers will calculate the concordance with the participant as the experimental unit rather than the biopsy, as each participant may have more than 1 biopsy. Target concordance rate is 70%. Concordance rate monitored using method described by Thall et al. (1995), and trial stopped if concordance rate is less than 70%.
1 day

Study Arms (1)

High-Resolution Microendoscopy (HRME) + Colposcopy

EXPERIMENTAL

Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.

Drug: ProflavineDevice: HRME ImagingBehavioral: Phone CallProcedure: ColposcopyDrug: Acetic Acid

Interventions

ProflavineDRUG

0.01% Proflavine applied topically to the cervix after colposcopy and HRME cervical images obtained.