Status:
TERMINATED
Screen and Treat for Cervical Cancer Prevention
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Bill and Melinda Gates Foundation
EngenderHealth
Conditions:
Cervical Cancer
Eligibility:
FEMALE
35-65 years
Phase:
PHASE3
Brief 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 "...
Detailed Description
Participants and Clinical Examinations: Unscreened, non-pregnant women 35-65 years of age are enrolled at three closely located clinical sites in Khayelitsha, South Africa. All women provide informed ...
Eligibility Criteria
Inclusion
- Has a cervix
- Never been screened for cervical cancer
- Not currently pregnant
Exclusion
- Has previously had a Pap smear
- Has previously undergone treatment for cervical squamous intraepithelial lesion (SIL)
- Have lesions suspicious for cancer, have large acetowhite lesions extending over 70% of the cervix or into endocervical canal, are unsuitable for cryotherapy because of severe atrophy, polyps, cervix distorted, cervix cannot be adequately visualized
- Is unable to cooperate with study procedures or tolerate the insertion of a speculum
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
7123 Patients enrolled
Trial Details
Trial ID
NCT00233727
Start Date
January 1 2000
End Date
May 1 2013
Last Update
July 9 2015
Active Locations (1)
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1
University of Cape Town
Cape Town, Western Cape, South Africa, 8001