Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer
- Conditions
- HPV Infection
- Interventions
- Biological: Human papillomavirus genotyping
- Registration Number
- NCT02809352
- Lead Sponsor
- CHU de Reims
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 348
- to live in the Ardennes department (France)
- affiliation to a health insurance organism
- 31 to 65 years old
- current follow-up for cervical cytological abnormalities
- history of hysterectomy
- reimbursement for a Pap smear in the last 3 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description women tested positive for hrHPV Human papillomavirus genotyping All women participating in START-HPV pilot program for cervical cancer screening and tested positive for hrHPV with the Hybrid Capture 2 test (Qiagen).
- Primary Outcome Measures
Name Time Method HPV genotyping 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chu Reims
🇫🇷France, Reims, France