Status:
COMPLETED
Mobile High-Resolution Microendoscopy (mHRME) for the Detection of Cervical Dysplasia in El Salvador
Lead Sponsor:
William Marsh Rice University
Collaborating Sponsors:
Basic Health International
M.D. Anderson Cancer Center
Conditions:
Cervical Cancer
Eligibility:
FEMALE
30-49 years
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 cer...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
1827 Patients enrolled
Trial Details
Trial ID
NCT04472455
Start Date
September 1 2015
End Date
April 2 2019
Last Update
July 15 2020
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