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

NCT ID: NCT02809352

Last Updated: 2016-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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HPV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Human papillomavirus genotyping

Intervention Type BIOLOGICAL

Interventions

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Human papillomavirus genotyping

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

31 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

France, Reims, France

Site Status

Countries

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France

Other Identifiers

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PJ12078

Identifier Type: -

Identifier Source: org_study_id

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