Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia

September 14, 2009 updated by: Lund University

Evaluation of the Use of Human Papillomavirus Persistence for Determination of the Treatment Efficacy Among Women With Cervical Intraepithelial Neoplasia, and for Prediction of Recurrence of Cervical Disease

The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.

Study Overview

Status

Completed

Conditions

Detailed Description

Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.

Study Type

Observational

Enrollment (Actual)

195

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

  • Sweden
      • Umeå, Sweden, 90185
        • Dept. obstetrics and gynecology, University hospital of Northern Sweden

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

195 women referred for treatment of cervical intraepithelial neoplasia in the cathment area of Umeå university hospital. All women had abnormal smears at enrollment.

Description

Inclusion Criteria:

  • Referral to Umeå university hospital for treatment due to abnormal Pap smear.

Exclusion Criteria:

  • Lack of informed consent.

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

Collaborators and Investigators

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

Sponsor

Lund University

Collaborators

Swedish Cancer Society

Investigators

  • Principal Investigator: Anna Söderlund Strand, PhD, Dept. medical microbiology, Malmö university hospital, Malmö, Sweden

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

February 1, 2001

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95-240

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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