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

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ClinicalTrials.gov Identifier: NCT03195218
Recruitment Status : Unknown
Verified June 2017 by Barretos Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborators:
William Marsh Rice University
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barretos Cancer Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intraepithelial Neoplasia Intraepithelial Neoplasm, Cervical Cervical Cancer Neoplasm Cervix Device: HRME examination Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1780 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Trial with a single arm
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of High Resolution Microendoscope in the Screening of Cervical Cancer Precursor Lesions in Brazil (UH3 - Brazil)
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: HRME examination
HRME 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
 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
Other Names:
  • Diagnostic tool
  • Microendoscope


Outcome Measures
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Primary Outcome Measures :
  1. Isolated accuracy of HRME [ Time Frame: Biopsy of uterine cervix will be performed during HRME / colposcopy examination ]
    Sensitivity and Specificity of CIN2+ and CIN3+ detection using HRME


Secondary Outcome Measures :
  1. Comparison of accuracy [ Time Frame: Biopsy of uterine cervix will be performed during HRME / colposcopy examination ]
    Comparison of sensitivity and specificity of CIN2+ and CIN3+ with colposcopy and VIA


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195218


Contacts
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Contact: Jose H Fregnani, PhD +55 17 33216600 ext 7086 mdfregnani@terra.com.br

Locations
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Brazil
Barretos Cancer Hospital Recruiting
Barretos, SP, Brazil, 14784400
Contact: Jose H Fregnani, PhD    17981325675    mdfregnani@terra.com.br   
Contact: Rui M Reis, PhD    17981252222    ruireis.hcb@gmail.com   
Sponsors and Collaborators
Barretos Cancer Hospital
William Marsh Rice University
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Director: Rui M Reis, PhD Barretos Cancer Hospital
More Information
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Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT03195218     History of Changes
Other Study ID Numbers: HRME-UH3
UH3CA189910 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: RedCap Platform will be used to share data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Barretos Cancer Hospital:
Cancer prevention
Diagnosis
Microendoscope
High Resolution Microendoscope
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type