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

This study has been completed.
Sponsor:
Collaborator:
Swedish Cancer Society
Information provided by:
Lund University
ClinicalTrials.gov Identifier:
NCT00931190
First received: June 30, 2009
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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
Human Papillomavirus Infection
Cervical Intraepithelial Neoplasia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Lund University:

Biospecimen Retention:   Samples With DNA

Cervical smear samples in physiologic saline.


Enrollment: 195
Study Start Date: February 2001
Study Completion Date: November 2005
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.

  Eligibility

Genders 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Lack of informed consent.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00931190

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

No publications provided

Responsible Party: Anna Söderlund Strand, Dept. Medical microbiology, Malmö university hospital, 20502 Malmö, Sweden
ClinicalTrials.gov Identifier: NCT00931190     History of Changes
Other Study ID Numbers: 95-240
Study First Received: June 30, 2009
Last Updated: September 14, 2009
Health Authority: Sweden: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Papillomavirus Infections
Carcinoma
DNA Virus Infections
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014