Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237562
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : May 5, 2006
National Cancer Institute (NCI)
Information provided by:
University of California, Irvine

Brief Summary:
  1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women;
  2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time;
  3. Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP);
  4. Determine satisfaction and compare it between women assigned to the SVP and the UCP;
  5. Determine the cost-effectiveness and compare it between the SVP and UCP

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Procedure: Large loop electrosurgical excision Phase 3

Detailed Description:
Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Single Visit Cervical Cancer Prevention Program
Study Start Date : July 1999

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Older than 18 years
  • No history of invasive cervical cancer
  • Not pregnant

Exclusion Criteria:

  • Absence of a cervix
  • Abnormal vaginal bleeding
  • Cervical cancer screening within the previous 12 months
  • A known bleeding disorder
  • Reluctance to be randomized
  • Unwillingness to follow the study protocol

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237562

United States, California
University of California, Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
National Cancer Institute (NCI)
Principal Investigator: Alberto Manetta, MD University of California, Irvine

Publications of Results: Identifier: NCT00237562     History of Changes
Other Study ID Numbers: R01CA076501 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: May 5, 2006
Last Verified: October 2005

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type