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

May 4, 2006 updated by: University of California, Irvine

Single Visit Cervical Cancer Prevention Program

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Registration Dates

First Submitted

October 10, 2005

First Submitted That Met QC Criteria

October 10, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 5, 2006

Last Update Submitted That Met QC Criteria

May 4, 2006

Last Verified

October 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA076501 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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