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

Summary

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.

Conditions

• Intraepithelial Neoplasia
• Intraepithelial Neoplasm, Cervical
• Cervical Cancer
• Neoplasm Cervix

Interventions

DEVICE

HRME examination

HRME will capture images from all areas considered abnormal by VIA and/or colposcopy. In addition, all four quadrants will be probed with HRME to ensure that any non-acetowhite lesions are also observed

Sponsors & Collaborators

• William Marsh Rice University

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Barretos Cancer Hospital

  lead OTHER

Principal Investigators

• Rui M Reis, PhD · Barretos Cancer Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2019-05-31

Completion

2019-05-31

Countries

• Brazil

Study Locations