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

Sponsor

CHU de Reims (Other)

Overall Status

Completed

CT.gov ID

NCT02809352

Collaborator

(none)

348

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HPV Infection	Biological: Human papillomavirus genotyping

Study Design

Study Type:

Observational

Actual Enrollment :

348 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

31 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Reims	France	Reims	France	51092

Sponsors and Collaborators

CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHU de Reims

ClinicalTrials.gov Identifier:

NCT02809352

Other Study ID Numbers:

PJ12078

First Posted:

Jun 22, 2016

Last Update Posted:

Jun 23, 2016

Last Verified:

Jun 1, 2016

Additional relevant MeSH terms:

Infections

Communicable Diseases

Papillomavirus Infections

Study Results

No Results Posted as of Jun 23, 2016