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

Brief Title

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

Official Title

Single Visit Cervical Cancer Prevention Program

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

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 Phase

Phase 3

Study Type

Interventional

Condition

Cervical Intraepithelial Neoplasia

Intervention

Large loop electrosurgical excision

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Start Date

July 1999

Eligibility 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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Alberto Manetta, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00237562

Organization ID

R01CA076501

Study Sponsor

University of California, Irvine

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Alberto Manetta, MD, Principal Investigator, University of California, Irvine

Verification Date

October 2005