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Screen and Treat for Cervical Cancer Prevention

NCT00233727 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7123

Last updated 2015-07-09

No results posted yet for this study

Summary

The study measures the impact of "screen-and-treat" on the prevalence of high-grade cervical intraepithelial neoplasia and cancer (CIN 2+). It is a three-arm, randomized clinical trial comparing two "screen-and-treat" approaches to delayed evaluation as a control. The primary outcome is biopsy-confirmed CIN 2+ at 6 months and significant complications within 6 months of randomization with continued follow-up to detect CIN2+ and other complications up to 36 months post-randomization.

Conditions

Interventions

PROCEDURE

HPV DNA Testing + Cryosurgery

Patients will undergo a "Screen and Treat" program utilizing HPV DNA testing of clinician-collected cervical samples, followed by cryosurgery of screen positive women.

PROCEDURE

VIA + Cryosurgery

Patients will undergo a "Screen and Treat" program utilizing visual inspection of the cervix with acetic acid (VIA), followed by cryosurgery of screen positive women.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • EngenderHealth

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Lynette Denny, MD · University of Cape Town

  • Thomas C Wright, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2006-04-30
Completion
2013-05-31

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

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 NCT00233727 on ClinicalTrials.gov