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

NCT04472455 | Completed

• 1 other identifier: 2017-347
• Study Type: observational
• Target: 1,827
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Accuracy of mHRME to detect CIN2+

  Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of mHRME to detect CIN2+.

  1-2 days

Secondary Outcomes (1)

• Comparison of different screening and triage strategies to detect CIN2+

  1-2 days

Study Arms (3)

Screen Negative Group

All women who screen negative at Visit 1.

Diagnostic Test: HRME

Screen Positive Group

All women who screened positive at Visit 1 and were invited to Visit 2

Diagnostic Test: HRME

10% Of Screen Negative Group

10% of women who screened negative at Visit 1 and were invited to Visit 2

Diagnostic Test: HRME

Interventions

HRME DIAGNOSTIC_TEST

10% Of Screen Negative Group; Screen Negative Group; Screen Positive Group

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• William Marsh Rice University: lead
• Basic Health International: collaborator
• M.D. Anderson Cancer Center: collaborator
• Albert Einstein College of Medicine: collaborator
• The Cleveland Clinic: collaborator

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Biospecimen

Retention: SAMPLES WITH DNA

Cervical swab samples are collected to test for HPV DNA

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mauricio Maza, MD

  Basic Health International

  PRINCIPAL INVESTIGATOR

• Rebecca Richards-Kortum, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

• Kathleen Schmeler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Malcolm Gillis University Professor, Professor of Bioengineering

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: September 1, 2015
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: July 15, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share