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

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ClinicalTrials.gov Identifier: NCT00931190
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Swedish Cancer Society
Information provided by:
Lund University

Tracking Information
First Submitted Date June 30, 2009
First Posted Date July 2, 2009
Last Update Posted Date September 15, 2009
Study Start Date February 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00931190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia
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
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cervical smear samples in physiologic saline.
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.
Condition
  • Human Papillomavirus Infection
  • Cervical Intraepithelial Neoplasia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June¬†30,¬†2009)
195
Original Actual Enrollment Same as current
Actual Study Completion Date November 2005
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Lack of informed consent.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT00931190
Other Study ID Numbers 95-240
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anna Söderlund Strand, Dept. Medical microbiology, Malmö university hospital, 20502 Malmö, Sweden
Study Sponsor Lund University
Collaborators Swedish Cancer Society
Investigators
Principal Investigator: Anna Söderlund Strand, PhD Dept. medical microbiology, Malmö university hospital, Malmö, Sweden
PRS Account Lund University
Verification Date September 2009