Mobile High-Resolution Microendoscopy (mHRME) for the Detection of Cervical Dysplasia in El Salvador

July 10, 2020 updated by: Rebecca Richards-Kortum, William Marsh Rice University
Evaluate the performance of the mHRME in a study of 3,000 women in San Salvador to assess whether mHRME imaging improves specificity of screening by VIA or HPV DNA without reducing sensitivity for cervical precancer and cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective cohort study. Eligibility is open to women 30-49 years old, who are not pregnant, have an intact cervix, and no history of cervical cancer.

Visit 1:

Patients will enroll at the screening clinic of the Instituto del Cáncer de El Salvador (El Salvador Cancer Institute, ICES). An informed consent will be obtained. They will be given a urine pregnancy test; if negative, two cervical samples will be collected. The first sample will be used to screen for HPV DNA. New technologies to screen for oncoproteins and HPV will be applied to the second sample. 3-5% acetic acid will also be applied to the cervix to perform the VIA. Images of the cervix will be taken and any personally identifiable information removed.

Visit 2:

All women with a positive VIA or HPV test will undergo additional evaluation. In addition, 10% of women in the double negative group (VIA-/HPV-) will be randomly selected for evaluation. This evaluation includes: Urine pregnancy test, VIA, colposcopy, Lugol's solution application, and a HRME. 3-5% acetic acid will be applied to the cervix to perform the VIA. Proflavine and Lugol's solution (2-5%) will be applied and once again the health care provider will record their impression for each of the abnormal lesions. Cervical images will be taken. Then, 0.01% proflavine will be topically applied to the cervix for 1 minute. Images will be obtained using the mHRME system of a visually normal site and then of all lesions identified by VIA, colposcopy, and/or Lugol's solution. If no lesions are identified by VIA, colposcopy, and/or Lugol's solution, mHRME images will be taken of each quadrant. Samples of abnormal areas identified by VIA, colposcopy, Lugol's solution, and/or mHRME will be collected for biopsy and ECC purposes. If the evaluation shows no abnormalities, a random sample will be collected from the squamocolumnar junction and an ECC will be performed (only if the patient is HPV positive). Two expert pathologists will review and classify the samples. All research results will be unbeknownst to them. They will use the following classification system: normal, CIN 1, CIN 2, CIN 3, AIS, or cancer, per standard criteria. Discrepant results are resolved by a third expert pathologist, with the final result being based on 2/3 agreement. If all three pathologists arrive at different diagnoses, all three will meet in person to review to reach a consensus diagnosis. Women with CIN 2+ will undergo an excision or cryotherapy, according to the treatment standard. Patients diagnosed with invasive cancer will be referred to gynecology/oncology.

The sensitivity, specificity, positive predictive value, and negative predictive value for each screening and triage method will be compared using histopathology as the gold standard. These results will enable us to compare the total number of women that could have received adequate and inadequate treatment based on five of the most predominant clinical scenarios: VIA alone, VIA/mHRME triage, HPV test alone, HPV/VIA triage, and HPV/mHRME triage.

Study Type

Observational

Enrollment (Actual)

1827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

This is a prospective cohort study. Eligibility is open to women 30-49 years old, who are not pregn ant, have an intact cervix and no history of cervical cancer

Description

Inclusion Criteria:

  1. Women who are between the ages of 30 and 49 years of age
  2. All women must have a negative urine or serum pregnancy test prior to any study procedure (within 7 days)
  3. Intact cervix (patients who have undergone previous LEEP, cone and/ or cryotherapy are not eligible)
  4. No history of invasive cervical cancer
  5. Able and willing to provide informed consent

Exclusion Criteria:

  1. Women < 30 years of age or over 49 years of age
  2. Women who have undergone a hysterectomy with removal of the cervix
  3. Women who have had a previous LEEP, Cold knife cone and/or cryotherapy
  4. Women who are pregnant or breastfeeding
  5. Women with a history of invasive cervical cancer
  6. Unable or unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screen Negative Group
All women who screen negative at Visit 1.
Screen Positive Group
All women who screened positive at Visit 1 and were invited to Visit 2
10% Of Screen Negative Group
10% of women who screened negative at Visit 1 and were invited to Visit 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of mHRME to detect CIN2+
Time Frame: 1-2 days
Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of mHRME to detect CIN2+.
1-2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of different screening and triage strategies to detect CIN2+
Time Frame: 1-2 days
Compare the sensitivities and specificities of the following theoretical strategies to detect CIN2+: VIA alone, VIA/mHRME triage, HPV test alone, HPV/VIA triage, and HPV/mHRME triage.
1-2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rebecca Richards-Kortum, PhD, William Marsh Rice University
  • Principal Investigator: Mauricio Maza, MD, Basic Health International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

April 2, 2019

Study Completion (Actual)

April 2, 2019

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

REDCap platform will be used to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on HRME

Subscribe