Mobile High-Resolution Microendoscopy (mHRME) for the Detection of Cervical Dysplasia in El Salvador
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Dysplasia
Study type: Observational

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.
    

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.
    

Intervention name(s): HRME
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
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
      
Biospecimen description: 
      Cervical swab samples are collected to test for HPV DNA