Screen and Treat for Cervical Cancer Prevention (SAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
EngenderHealth, New York
University of Cape Town
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00233727
First received: October 4, 2005
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Procedure: HPV DNA Testing + Cryosurgery
Procedure: VIA + Cryosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Two Screen-and-Treat Approaches for the Prevention of Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Efficacy of "Screen and Treat" + Cryosurgery [ Time Frame: Up to 12 months from entry into the study ] [ Designated as safety issue: No ]

    Cervical Intraepithelial Neoplasia (CIN) Grade 2 or 3 or Cervical Cancer:

    To determine the reduction in prevalence of biopsy-confirmed high-grade SIL (HiSIL) when a "Screen and Treat" program utilizing visual inspection of the cervix with acetic acid (VIA) or HPV DNA followed by immediate cryosurgery of screen positive women is carried out by mid-level practitioners without the use of colposcopy in a low-resource setting.



Secondary Outcome Measures:
  • HIV incidence [ Time Frame: 6 months after entry into study ] [ Designated as safety issue: No ]
    Comparison of the rates of HIV seroconversion in women treated using cryosurgery with that of demographically similar, untreated women.

  • Safety of Cryosurgery [ Time Frame: Up to 12 months from entry into study ] [ Designated as safety issue: Yes ]
    To determine the complication rate of cryosurgery by evaluating the occurrence of any severe adverse events (e.g. bleeding, infection)associated with the use of cryosurgery.


Estimated Enrollment: 7200
Study Start Date: January 2000
Estimated Study Completion Date: September 2011
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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: 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.
Other Name: HPV DNA Testing + Cryosurgery
Active Comparator: 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.
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.
Other Name: VIA + Cryosurgery
No Intervention: Delayed Evaluation and Treatment
Patients will undergo a similar screening process at entry, but will be randomized to have evaluation and treatment delayed until 6 months after screening.

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 consent, receive counseling for confidential HIV serotesting, a questionnaire, a pregnancy test if not postmenopausal, anonymous HIV serotesting, and a vaginal speculum examination by nurses trained in visual inspection of the cervix with acetic acid (VIA). Cervical specimens are obtained for testing for N. gonorrhea, Chlamydia trachomatis and high-risk types of HPV, and cytology. The cervix is washed with 5% acetic acid and inspected for gross abnormalities or areas of acetowhitening and a 35 mm. photograph taken. Women with significant cervicitis or vulvovaginitis are treated using the syndromic approach. N. gonorrhea or Chlamydia trachomatis positive women receive appropriate therapy. A positive VIA examination is defined as any acetowhite lesion and no attempt is made to differentiate the acetowhitening of metaplasia from CIN. Women with lesions suspicious for cancer, large acetowhite lesions extending over 70% of the cervix or into endocervical canal, and 374 unsuitable for cryotherapy due to severe atrophy, polyps, cervix distorted, cervix not adequately visualized are excluded. These women are referred to colposcopy.

Women are asked to return 2-6 days later for randomization to either: (1) HPV arm in which all HPV DNA positive women receive cryotherapy; (2) VIA arm in which all VIA positive women receive cryotherapy; and (3) a delayed evaluation arm in which women are followed untreated, irrespective of HPV or VIA status. Randomization is done at a patient level using a computer-generated randomization schedule with arm assignments provided to the clinics in sealed envelopes. Cryotherapy is performed by a nurse using N2O and a cryosurgical unit (Wallach Surgical Devices, Orange, CT) using two 3-minute freezes. Cytology results are not available at the time of cryotherapy. Both treated and untreated women are asked to return at 4 weeks for a questionnaire.

At 6 months, colposcopy is done by a physician blinded to arm and clinical information. All acetowhite lesions are biopsied and all have an endocervical curettage. Women with CIN 2+ are treated with LEEP. Examinations in women who became pregnant during the study are postponed until three months post-partum. Blood for anonymous HIV serotesting is obtained. All women who were HPV or VIA-positive at enrollment and a subset who were HPV and VIA-negative (all women enrolled in 2002) are scheduled for repeat colposcopy at 12 months, 24 months and 36 months post-randomization. At these visits, cervical samples are collected and colposcopy and biopsy if indicated is performed.

Laboratory Testing: HPV testing is done using the Hybrid Capture 2 HPV DNA assay and high-risk probe mixture (Digene Corporation, Gaithersburg, MD) at the University of Cape Town. Biopsies are processed at Columbia University and blindly evaluated by a single pathologist.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has a cervix
  • Never been screened for cervical cancer
  • Not currently pregnant

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233727

Locations
South Africa
University of Cape Town
Cape Town, Western Cape, South Africa, 8001
Sponsors and Collaborators
Columbia University
Bill and Melinda Gates Foundation
EngenderHealth, New York
University of Cape Town
Investigators
Study Director: Lynette Denny, MD University of Cape Town
Principal Investigator: Thomas C Wright, MD Columbia University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Carr Wright, Columbia University Medical Center
ClinicalTrials.gov Identifier: NCT00233727     History of Changes
Obsolete Identifiers: NCT00494000
Other Study ID Numbers: AAAB3373
Study First Received: October 4, 2005
Last Updated: February 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
cervical cancer
cervical intraepithelial neoplasia
prevention
cryotherapy
HPV testing
cytology

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 11, 2014