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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00237562
First received: October 10, 2005
Last updated: May 4, 2006
Last verified: October 2005
History of Changes
  Purpose
  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 Intervention Phase
Cervical Intraepithelial Neoplasia
 Procedure: Large loop electrosurgical excision
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Single Visit Cervical Cancer Prevention Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Study Start Date: July 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237562

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

Publications:

ClinicalTrials.gov Identifier: NCT00237562     History of Changes
Other Study ID Numbers: R01 CA76501
Study First Received: October 10, 2005
Last Updated: May 4, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013