HRME in the Screening of Cervical Cancer Precursor Lesions in Brazil (UH3 - Brazil)
UH3
Validation of High Resolution Microendoscope in the Screening of Cervical Cancer Precursor Lesions in Brazil (UH3 - Brazil)
2 other identifiers
interventional
1,780
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJune 22, 2017
June 1, 2017
2 years
June 20, 2017
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Isolated accuracy of HRME
Sensitivity and Specificity of CIN2+ and CIN3+ detection using HRME
Biopsy of uterine cervix will be performed during HRME / colposcopy examination
Secondary Outcomes (1)
Comparison of accuracy
Biopsy of uterine cervix will be performed during HRME / colposcopy examination
Study Arms (1)
HRME examination
EXPERIMENTALHRME will capture images from all areas considered abnormal by VIA (visual inspection with acetic acid) and/or colposcopy. In addition, all four quadrants will be probed with HRME to ensure that any non-acetowhite lesions are also observed
Interventions
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
Eligibility Criteria
You may qualify if:
- Women aged 18 years and older;
- 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");
- Women with intact cervix or previously submitted to LEEP (loop electrosurgical excision procedure), cone or cryotherapy, with the presence of the cervix;
- Women of childbearing potential should have a negative urine or blood pregnancy test;
- Ability to understand and willing to provide informed consent document.
You may not qualify if:
- Women under 18 years old;
- Women who have undergone hysterectomy with removal of the cervix;
- Women with known allergy to proflavine or acriflavine;
- Women who are pregnant or nursing at the time of enrollment;
- Incapacitated women or in vulnerable situations or who are not willing to give consent;
- Women who belong to the indigenous community.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barretos Cancer Hospitallead
- William Marsh Rice Universitycollaborator
- M.D. Anderson Cancer Centercollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Barretos Cancer Hospital
Barretos, São Paulo, 14784400, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rui M Reis, PhD
Barretos Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 22, 2017
Study Start
June 1, 2017
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
June 22, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
RedCap Platform will be used to share data.