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

NCT02809352 | Completed

• 1 other identifier: PJ12078
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

women tested positive for hrHPV

All women participating in START-HPV pilot program for cervical cancer screening and tested positive for hrHPV with the Hybrid Capture 2 test (Qiagen).

Biological: Human papillomavirus genotyping

Interventions

Human papillomavirus genotyping BIOLOGICAL

women tested positive for hrHPV

Eligibility Criteria

• Age: 31 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who participate in START-HPV pilot screening program and tested positive for high-risk HPV

You may qualify if:

• to live in the Ardennes department (France)
• affiliation to a health insurance organism
• to 65 years old

You may not qualify if:

• current follow-up for cervical cytological abnormalities
• history of hysterectomy
• reimbursement for a Pap smear in the last 3 years

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

France, Reims, 51092, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

FR (1)