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

HPV Infection Clinical Trial

— Epi-START  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809352
• Other study ID #: PJ12078
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: June 22, 2016
• Start date: July 2012

Study information

• Verified date: June 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 31 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• HPV Infection
• Infection

Intervention

Biological:
• Human papillomavirus genotyping

Locations

Country	Name	City	State
France	Chu Reims	France	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV genotyping	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	Day 0	No