HRME: Screening for Cervical Cancer and Its Precursors in Low-Resource Settings

NCT02494310 | Completed

• 1 other identifier: HRME-UH2
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplasia of the Uterine Cervix; Cancer Prevention; Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• Treatment completion rate.

  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.

  Participants will be followed for two years.

Secondary Outcomes (1)

• Efficacy (ability to detect CIN 2+ in women with previous abnormal Pap test).

  6 months

Study Arms (2)

HRME - Prevention Mobile Unit

EXPERIMENTAL

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

HRME - Barretos Cancer Hospital

EXPERIMENTAL

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

Interventions

High-Resolution Microendoscopy Imaging DEVICE

Innovative technique to evaluate epithelial cell morphology in situ. The device is not invasive and does not exchange energy with human body.

Also known as: HRME

HRME - Barretos Cancer Hospital; HRME - Prevention Mobile Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead
• William Marsh Rice University: collaborator
• M.D. Anderson Cancer Center: collaborator
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Barretos Cancer Hospital

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 10, 2015
• Study Start: September 1, 2015
• Primary Completion: August 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02