AzTrials
AzTrials

Cervical CancerPhase 3SATNCT00233727

Screen and Treat for Cervical Cancer Prevention

A Phase 3 study testing HPV DNA Testing + Cryosurgery and VIA + Cryosurgery in people with Cervical Cancer, run by Columbia University at 1 site in South Africa.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
HPV DNA Testing + Cryosurgery and VIA + Cryosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,123 participants
Where
1 siteSouth Africa
Study dates
Jan 2000to May 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • University of Cape Town

    Cape Town, Western Cape, 8001

Other trials in South Africa

About this study

Official title: Safety and Efficacy of Two Screen-and-Treat Approaches for the Prevention of Cervical Cancer

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.

Read the 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.

Conditions
Cervical Cancer
Being tested
HPV DNA Testing + Cryosurgery, VIA + Cryosurgery
Keywords
cervical cancer, cervical intraepithelial neoplasia, prevention, cryotherapy, HPV testing, cytology
Medical subject headings
Uterine Cervical Neoplasms, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV DNA Testing + CryosurgeryProcedure or surgery

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

  • VIA + CryosurgeryProcedure or surgery

    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.

Study groups in NCT00233727
Study groupRoleWhat they receive
HPV DNA Testing + CryosurgeryActive comparatorPatients will undergo a "Screen and Treat" program utilizing HPV DNA testing of clinician-collected cervical samples, followed by cryosurgery of screen positive women.
Receives: Procedure: HPV DNA Testing + Cryosurgery
VIA + CryosurgeryActive comparatorPatients will undergo a "Screen and Treat" program utilizing visual inspection of the cervix with acetic acid (VIA), followed by cryosurgery of screen positive women.
Receives: Procedure: VIA + Cryosurgery
Delayed Evaluation and TreatmentNo interventionPatients will undergo a similar screening process at entry, but will be randomized to have evaluation and treatment delayed until 6 months after screening.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of "Screen and Treat" + Cryosurgery

    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.

    Measured: Up to 12 months from entry into the study

Secondary outcomes (2)

  1. HIV incidence

    Comparison of the rates of HIV seroconversion in women treated using cryosurgery with that of demographically similar, untreated women.

    Measured: 6 months after entry into study

  2. Safety of Cryosurgery

    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.

    Measured: Up to 12 months from entry into study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2005 (estimated)
  2. Study startJan 2000
  3. Primary completionApr 2006
  4. Study completionMay 2013

Why it stopped: PI left University

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7,123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00233727
Sponsor's protocol ID
AAAB3373
Acronym
SAT
Status last verified
Jul 2015
First submitted
4 Oct 2005
Last updated
9 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Denny L, Kuhn L, De Souza M, Pollack AE, Dupree W, Wright TC Jr. Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial. JAMA. 2005 Nov 2;294(17):2173-81. doi: 10.1001/jama.294.17.2173.

    PubMed 16264158

  • Kuhn L, Wang C, Tsai WY, Wright TC, Denny L. Efficacy of human papillomavirus-based screen-and-treat for cervical cancer prevention among HIV-infected women. AIDS. 2010 Oct 23;24(16):2553-61. doi: 10.1097/QAD.0b013e32833e163e.

    PubMed 20706107

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HPV DNA Testing + Cryosurgery and VIA + Cryosurgery in people with Cervical Cancer, run by Columbia University at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: PI left University). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of "Screen and Treat" + Cryosurgery (time frame: Up to 12 months from entry into the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00233727, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.

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