HRME in the Screening of Cervical Cancer Precursor Lesions in Brazil (UH3 - Brazil) (UH3)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intraepithelial Neoplasia Intraepithelial Neoplasm, Cervical Cervical Cancer Neoplasm Cervix | Device: HRME examination | Not Applicable |

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 |

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:
|
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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
Contact: Jose H Fregnani, PhD | +55 17 33216600 ext 7086 | mdfregnani@terra.com.br |
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 |
Study Director: | Rui M Reis, PhD | Barretos Cancer Hospital |
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. |
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 |
Cancer prevention Diagnosis Microendoscope High Resolution Microendoscope |
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 |