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Clinical Trials/NCT02809352
NCT02809352
Completed
Not Applicable

Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program Entitled START-HPV (STudy of Primary Screening in the ARdennes Department by Testing for HPV Infection)

CHU de Reims1 site in 1 country348 target enrollmentJuly 2012
ConditionsHPV Infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HPV Infection
Sponsor
CHU de Reims
Enrollment
348
Locations
1
Primary Endpoint
HPV genotyping
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2014
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • to live in the Ardennes department (France)
  • affiliation to a health insurance organism
  • 31 to 65 years old

Exclusion Criteria

  • current follow-up for cervical cytological abnormalities
  • history of hysterectomy
  • reimbursement for a Pap smear in the last 3 years

Outcomes

Primary Outcomes

HPV genotyping

Time Frame: Day 0

DNA extraction from cervical smears (DNAPap Cervical Sampler device, Qiagen) or from self-collected vaginal lavages (Delphi-screener device, DelphiBioscience) and HPV genotyping with the Multiplex HPV Genotyping kit© (Multimetrix, Progen) based on a Luminex technology

Study Sites (1)

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