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)
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.
Investigators
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