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HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings (HRME-UH2)

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ClinicalTrials.gov Identifier: NCT02494310
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : February 3, 2017
Sponsor:
Collaborators:
William Marsh Rice University
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jose Humberto Tavares Guerreiro Fregnani, PhD, Barretos Cancer Hospital

Brief Summary:
A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME. The mobile diagnostic and treatment unit will be equipped with the tools and infrastructure necessary to perform HRME, VIA, colposcopy, biopsy and treatment with cryotherapy. A team of a colposcopist, nurse, nursing assistant, and driver will staff the mobile diagnostic and treatment unit. The unit will travel to offer follow-up diagnostic and treatment services to women who have screened positive during a prior visit with the mobile screening unit. The mobile diagnostic and treatment unit will be constructed and maintained at BCH.

Condition or disease Intervention/treatment Phase
Neoplasia of the Uterine Cervix Cancer Prevention Cervical Intraepithelial Neoplasia Device: High-Resolution Microendoscopy Imaging Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Point‐of‐Care, Real‐Time Optical Imaging to Enable Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HRME - Prevention Mobile Unit
Procedures to be done in the mobile unit (van): Visual inspection will be performed with 5% acetic acid (VIA) applied to the cervix followed by standard colposcopy. Proflavine (0.01%) will then be applied topically. Lugol's solution will then be applied and colposcopy performed and abnormal lesions noted. HRME images will be acquired from any areas that are abnormal by VIA and/or colposcopy. VIA, colposcopy and HRME observations will recorded by quadrant. Any abnormal areas by VIA and/or colposcopy will be biopsied. If no abnormal areas are noted, one cervical biopsy will be obtained from a normal appearing area with a HRME image of this area obtained.
Device: High-Resolution Microendoscopy Imaging
Innovative technique to evaluate epithelial cell morphology in situ. The device is not invasive and does not exchange energy with human body.
Other Name: HRME

Experimental: HRME - Barretos Cancer Hospital
Procedures to be done at Barretos Cancer Hospital: Visual inspection will be performed with 5% acetic acid (VIA) applied to the cervix followed by standard colposcopy. Proflavine (0.01%) will then be applied topically. Lugol's solution will then be applied and colposcopy performed and abnormal lesions noted. HRME images will be acquired from any areas that are abnormal by VIA and/or colposcopy. VIA, colposcopy and HRME observations will recorded by quadrant. Any abnormal areas by VIA and/or colposcopy will be biopsied. If no abnormal areas are noted, one cervical biopsy will be obtained from a normal appearing area with a HRME image of this area obtained.
Device: High-Resolution Microendoscopy Imaging
Innovative technique to evaluate epithelial cell morphology in situ. The device is not invasive and does not exchange energy with human body.
Other Name: HRME




Primary Outcome Measures :
  1. Treatment completion rate. [ Time Frame: Participants will be followed for two years. ]
    Treatment completion for screen-positive women invited to visit a mobile diagnostic and treatment unit in their local area compared to those who are asked to return to a central facility for diagnosis and treatment.


Secondary Outcome Measures :
  1. Efficacy (ability to detect CIN 2+ in women with previous abnormal Pap test). [ Time Frame: 6 months ]
    Efficacy of HRME in detecting CIN 2+ in women with previous abnormal Pap test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with an abnormal Pap test (atypical squamous cells of undetermined significance or more severe interpretations [≥ASC-US])
  2. Women with an intact cervix (patients who have undergone previous LEEP, cone and/or cryotherapy are eligible)
  3. Women of childbearing potential must have a negative urine or serum pregnancy test
  4. Women who are at least 18 years of age or older
  5. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

Exclusion Criteria:

  1. Women <18 years of age
  2. Women who have undergone a hysterectomy with removal of the cervix
  3. Women with a known allergy to proflavine or acriflavine
  4. Women who are pregnant or nursing
  5. Women unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)

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Responsible Party: Jose Humberto Tavares Guerreiro Fregnani, PhD, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02494310     History of Changes
Other Study ID Numbers: HRME-UH2
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type