Open Access Study protocol

Rationale and design of a multicenter prospective cohort study for the eVALuation and monitoring of HPV infections and relATEd cervical diseases in high-risk women (VALHIDATE study)

Giovanna Orlando1*, Elisabetta Tanzi2, Liliane Chatenoud3, Maria Gramegna4, Giuliano Rizzardini5 and VALHIDATE Study Group

Author Affiliations

1 STD Unit, Infectious Diseases II, L Sacco University Hospital Via GB Grassi, 74 - 20157, Milan, Italy

2 Department of Biomedical Sciences for Health, University of Milan, Milan, Italy

3 Lifestyle Habits and Prevention Unit, Laboratory of Epidemiology, Department of Epidemiology, Pharmacological Research Institute “Mario Negri”, Milan, Italy

4 Unità Organizzativa Governo della prevenzione e tutela sanitaria, Direzione Generale Sanità, Regione Lombardia, Milan, Italy

5 Department of Infectious Diseases, L Sacco University Hospital, Milan, Italy

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BMC Cancer 2012, 12:204  doi:10.1186/1471-2407-12-204

Published: 30 May 2012

Abstract

Background

Pap screening, an effective method for cervical cancer prevention, is now supported by molecular human papillomavirus (HPV) testing. Recently commercialised preventive vaccines also provide new tools for the primary prevention of cervical cancer. To determine appropriate prevention strategies, the Health General Direction, Lombardy Region, funded a project that aims to characterize and monitor HPV infections and related cervical diseases in high-risk women.

Methods/design

VALHIDATE is a 5-year multicentre open prospective cohort study. It will recruit 7000 consenting women aged 13–65 years to provide information about the local biomolecular epidemiology of HPV infection and cervical diseases in high-risk women recruited from nine clinical centres and one faith-based organisation. The study will estimate the overall and type-specific prevalence of HPV infection and cervical abnormalities. It also aims to compare standard Pap screening with biomolecular screening, and to assist in the design of targeted regional prevention programs directed specifically at high-risk groups. Three groups of high-risk women: 1000 HIV-infected women (aged 26–65 years), 1000 recent migrant women (aged 26–65 years) and 3000 young women (aged 13–26 years) and 1 control group: 2000 women (aged 26–45 years) attending a spontaneous screening program, will be recruited. Sample sizes will be revised after the first year. Adult participants will undergo conventional cervical cytology, HPV DNA screening and genotyping. Paediatric participants will undergo HPV DNA testing and genotyping of urine samples. HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form. Overall and stratified prevalences will be estimated to analyse the associations between HPV infection and selected characteristics. Logistic regression models will be used to estimate crude and adjusted odds ratios. Cox proportional hazard models will be used to estimate hazard ratios over time and between groups.

Discussion/main expected results

This study will provide substantial insight into HPV infections and related cervical diseases in high-risk groups and will help determine appropriate regional cervical cancer prevention strategies.

Keywords:
Cervical cancer; Prevention; HPV; Epidemiology; Cytology screening; Molecular screening