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

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: NCT00931190
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : September 15, 2009
Swedish Cancer Society
Information provided by:
Lund University

Brief Summary:
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.

Condition or disease
Human Papillomavirus Infection Cervical Intraepithelial Neoplasia

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.

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Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : February 2001
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Cervical smear samples in physiologic saline.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • Lack of informed consent.

Information from the National Library of Medicine

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): NCT00931190

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Dept. obstetrics and gynecology, University hospital of Northern Sweden
Umeå, Sweden, 90185
Sponsors and Collaborators
Lund University
Swedish Cancer Society
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Principal Investigator: Anna Söderlund Strand, PhD Dept. medical microbiology, Malmö university hospital, Malmö, Sweden

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Responsible Party: Anna Söderlund Strand, Dept. Medical microbiology, Malmö university hospital, 20502 Malmö, Sweden Identifier: NCT00931190    
Other Study ID Numbers: 95-240
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Papillomavirus Infections
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Tumor Virus Infections