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Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02809352
Acronym
Epi-START
Enrollment
348
Registered
2016-06-22
Start date
2012-07-31
Completion date
Unknown
Last updated
2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Infection

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.

Interventions

BIOLOGICALHuman papillomavirus genotyping

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
31 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HPV genotypingDay 0DNA 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026