HRME in the Screening of Cervical Cancer Precursor Lesions in Brazil (UH3 - Brazil)

STUDY PURPOSES: This study aims to evaluate a high resolution microendoscope (HRME): 1) To assess the sensitivity and specificity of the HRME device in the detection of cervical intraepithelial neoplasia grade 2 (CIN2) or histologically more severe lesion (NIC2+) and cervical intraepithelial neoplasia grade 3 (CIN3) or histologically more severe lesion (NIC3+) in a comprehensive case-by-case basis; 2) Compare the accuracy of the HRME device with acetic acid visualization (VIA) and colposcopy. METHODOLOGY: 1,780 women with abnormal Pap Smears (ASCUS+) or positive high-risk human papillomavirus (HPV) test in the cervix performed in the Barretos Cancer Hospital (HCB, Barretos, Brazil) screening program will be recruited, either at Mobile Prevention Units or Fixed Units, who have been referred for diagnostic investigation with colposcopy. The invitation for women to participate in the study will be made immediately before the medical consultation for colposcopy, in the Prevention Department of Barretos Cancer Hospital. Women who decide to participate in this study will sign an Informed Consent Form after invitation and relevant explanations, which will be provided by the researcher in charge or by a representative with previous training appointed by him for the application of the Form in question. During the colposcopy examination, the HRME device will be used to check the presence of precursor lesions in the cervix. HRME will capture images from all areas considered abnormal by VIA and/or colposcopy. Any abnormal areas detected by VIA and/or colposcopy will undergo a biopsy. If no abnormal area is observed, a cervical microbiopsy will be obtained from an apparently normal area examined using HRME. If during the study a precursor disease or cervical cancer is detected in any woman, an appropriate treatment will be offered by Barretos Cancer Hospital according to an institutional protocol.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

1. Women aged 18 years and older;
2. Women with abnormal cervical cytology (atypical squamous cells of undetermined significance or more severe interpretations \[≥ASC-US\]) or positive high-risk HPV test on cervical samples. Additionally, 10% of the study population will consist of women with no change in cervical cytology and HPV test in order to check verification bias (see further explanations in "6.2. Sample calculation");
3. Women with intact cervix or previously submitted to LEEP (loop electrosurgical excision procedure), cone or cryotherapy, with the presence of the cervix;
4. Women of childbearing potential should have a negative urine or blood pregnancy test;
5. Ability to understand and willing to provide informed consent document.

Exclusion Criteria:

1. Women under 18 years old;
2. Women who have undergone hysterectomy with removal of the cervix;
3. Women with known allergy to proflavine or acriflavine;
4. Women who are pregnant or nursing at the time of enrollment;
5. Incapacitated women or in vulnerable situations or who are not willing to give consent;
6. Women who belong to the indigenous community.