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

This study is a prospective cohort study and aimed to evaluate the performance of the mobile High-Resolution Microendoscopy (mHRME) in a study of 3,000 women in San Salvador, the capital of El Salvador, to assess whether mHRME imaging improves specificity of screening by visual inspection with acetic acid (VIA) or human papillomavirus (HPV) DNA assays without reducing sensitivity for cervical precancer and cancer. Patients were first enrolled at the screening clinic of the Instituto del Cáncer de El Salvador (El Salvador Cancer Institute, ICES), where cervical samples and images of the cervix were taken to conduct a VIA or HPV test. For their second visit, women with a positive VIA or HPV test underwent additional evaluation: urine pregnancy test, VIA, colposcopy, Lugol's solution application, and a HRME.

Study design
Cohort

Number of participants at first data collection

3,000 (participants)

Age at first data collection

30 - 49 years (participants)

Participant year of birth

Varied (participants)

Participant sex
Female

Representative sample at baseline?
No

Sample features

Patients and clinical populations
Dataset details

Country

El Salvador

Year of first data collection

2015

Primary Institutions

William Marsh Rice University

Links

trial.medpath.com/clinical-trial/ec9ed85d1e76bc49/nct04472455-mobile-high-resolution-microendoscopy-cervical-dysplasia-el-salvador

clinicaltrials.gov/show/NCT04472455

Profile paper DOI

doi.org/10.1002/ijc.33454

Funders

National Institutes of Health (NIH)

Ongoing?
No

Data types collected

Quantitative data collection
  • Physical or biological assessment (e.g. blood, saliva, gait, grip strength, anthropometry)
Qualitative data collection
  • None
Neuroimaging data collection
  • None
Linked or secondary data
  • None
Features

Engagement

  • None
  • Keywords

    Cervical cancer
    Clinical assessments
    Disease detection
    Disease prevalence
    Reproductive health
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