Screen and Treat for Cervical Cancer Prevention

NCT00233727 | Terminated Phase 3

• 1 other identifier: AAAB3373
• Study Type: interventional
• Target: 7,123
• Locations: 1 country
• Sites: 1

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 "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

Cervical Cancer

Keywords

cervical cancer; cervical intraepithelial neoplasia; prevention; cryotherapy; HPV testing; cytology

Outcome Measures

Primary Outcomes (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.

  Up to 12 months from entry into the study

Secondary Outcomes (2)

• HIV incidence

  6 months after entry into study

• Safety of Cryosurgery

  Up to 12 months from entry into study

Study Arms (3)

HPV DNA Testing + Cryosurgery

ACTIVE COMPARATOR

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

VIA + Cryosurgery

ACTIVE COMPARATOR

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

Delayed Evaluation and Treatment

NO INTERVENTION

Patients will undergo a similar screening process at entry, but will be randomized to have evaluation and treatment delayed until 6 months after screening.

Interventions

HPV DNA Testing + Cryosurgery PROCEDURE

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

HPV DNA Testing + Cryosurgery

VIA + Cryosurgery PROCEDURE

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.

VIA + Cryosurgery

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Bill and Melinda Gates Foundation: collaborator
• EngenderHealth: collaborator
• University of Cape Town: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, 8001, South Africa

Location

Related Publications (2)

• 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.

  PMID: 16264158 RESULT

• 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.

  PMID: 20706107 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Lynette Denny, MD

  University of Cape Town

  STUDY DIRECTOR

• Thomas C Wright, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: January 1, 2000
• Primary Completion: April 1, 2006
• Study Completion: May 1, 2013
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

ZA (1)