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Cervical Cancer Screening Study in Brazil

NCT02335372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-10-12

No results posted yet for this study

Summary

Objectives:

Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for detection of cervical neoplasia in Brazil.

Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate the highest degree of correlation with disease state.

Conditions

Interventions

PROCEDURE

Wide-Field White Light Imaging

Initial wide-field white light images acquired of cervix in unpolarized and cross-polarized modes during cervical colposcopy.

DRUG

Acetic Acid

3-6% acetic acid applied to cervix after wide-field while light imaging during colposcopy.

DRUG

Proflavine Solution

Topical application of 0.01% proflavine solution applied for 1 minute to cervix after sites for biopsy have been identified during colposcopy.

PROCEDURE

Wide-Field Fluorescence Imaging

Wide-field imaging in fluorescence mode performed during cervical colposcopy after topical proflavine solution applied.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Kathleen Schmeler, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2021-10-07
Completion
2021-10-07

Countries

  • Brazil

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 NCT02335372 on ClinicalTrials.gov