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OpenTrials
Completed

NCT Number: NCT02335372

Cervical Cancer Screening Study in Brazil

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barretos Cancer Hospital

Barretos, 14784-400, Brazil

About this study

Wide-field and high-resolution images of precancerous cervical lesions and normal uterine cervix will be obtained by imaging 357 patients, recruited from women presenting for colposcopic evaluation from the Prevention Department at Barretos Cancer Hospital, a MDACC Sister Institution, in Barretos, Brazil. Barretos Cancer Hospital will serve as the lead site for the study

Initial wide-field white light images will be acquired in unpolarized and cross-polarized modes before application of 3-6% acetic acid. Routine colposcopy involves visual inspection of the cervix for aceto-whitening and will be followed by a second pair of white-light images in each polarization mode. The clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image. Topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed. The clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each. The high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens.

The entire imaging procedure should add less than 10 minutes to the standard colposcopy procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing colposcopy
  • 18 years of age or older
  • Negative pregnancy test
  • Subjects must be willing and able to provide informed consent

Exclusion criteria

  • Patients under 18 years of age
  • Positive pregnancy test
  • Subjects unwilling and unable to provide informed consent

Treatment and study plan

Wide-Field White Light Imaging

Procedure

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

Acetic Acid

Drug

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

Proflavine Solution

Drug

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

Wide-Field Fluorescence Imaging

Procedure

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

Primary outcomes

  1. Area Under the Receiver Operating Characteristic (ROC) Curve for Classifying Cervical Tissue into One of 2 Diagnostic Categories

    Time frame: 1 day

    Data used to develop an algorithm to maximize the area under the receiver operating characteristic (ROC) curve for classifying tissue into one of 2 diagnostic categories (high grade squamous intraepithelial lesions; normal or low grade squamous intraepithelial lesions). Descriptive statistics used to summarize the demographic and clinical characteristics of patients by diagnostic category. Descriptive statistics and boxplots used to summarize nuclear size and N/C by diagnostic category. Logistic regression methods used with the training set to model the logit of the probability of being classified as a high grade squamous intraepithelial lesion and to identify the parameters and threshold values which maximize the area under the ROC curve.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

A Pilot Study of a Low-Cost Optical Imaging Tool for Cervical Cancer Screening in Brazil

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2015
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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