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

NCT02494310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-02-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Barretos Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2016-08-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02494310 on ClinicalTrials.gov