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

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.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

31 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Chu Reims

France, Reims, 51092

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human papillomavirus genotyping

Biological

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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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)

Acronym: Epi-START

Important dates

Study start: 2012
Primary completion: 2014
First posted: Jun 22, 2016
Registry last updated: Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed