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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).

Abstract 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.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title bmc cancer
Publication Year Start




PMID- 22646512
OWN - NLM
STAT- MEDLINE
DCOM- 20130523
LR  - 20170220
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 12
DP  - 2012 May 30
TI  - 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).
PG  - 204
LID - 10.1186/1471-2407-12-204 [doi]
AB  - 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.
FAU - Orlando, Giovanna
AU  - Orlando G
AD  - STD Unit, Infectious Diseases II, L Sacco University Hospital Via GB Grassi,
      Milan, Italy. [email protected]
FAU - Tanzi, Elisabetta
AU  - Tanzi E
FAU - Chatenoud, Liliane
AU  - Chatenoud L
FAU - Gramegna, Maria
AU  - Gramegna M
FAU - Rizzardini, Giuliano
AU  - Rizzardini G
CN  - VALHIDATE Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120530
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (DNA, Viral)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Cervical Intraepithelial Neoplasia/epidemiology/*prevention & control/virology
MH  - Cross-Sectional Studies
MH  - DNA, Viral/genetics
MH  - Female
MH  - Genotype
MH  - Human papillomavirus 16/genetics
MH  - Human papillomavirus 18/genetics
MH  - Humans
MH  - Italy/epidemiology
MH  - Mass Screening/methods
MH  - Middle Aged
MH  - Mutation
MH  - Papillomaviridae/classification/*genetics
MH  - Papillomavirus Infections/epidemiology/*prevention & control/virology
MH  - Phylogeny
MH  - Prospective Studies
MH  - Risk Factors
MH  - Uterine Cervical Diseases/epidemiology/*prevention & control/virology
MH  - Uterine Cervical Neoplasms/epidemiology/*prevention & control/virology
MH  - Vaginal Smears/methods
MH  - Young Adult
PMC - PMC3512493
OID - NLM: PMC3512493
IR  - Antonacci MC
FIR - Antonacci, Maria Concetta
IR  - Arcidiacono I
FIR - Arcidiacono, Irene
IR  - Bertuccio P
FIR - Bertuccio, Paola
IR  - Bianchi S
FIR - Bianchi, Silvia
IR  - Boero V
FIR - Boero, Veronica
IR  - Cambie G
FIR - Cambie, Giuseppe
IR  - Esposito S
FIR - Esposito, Susanna
IR  - Falchetti M
FIR - Falchetti, Marcella
IR  - Fasolo MM
FIR - Fasolo, Michela Maria
IR  - Galli C
FIR - Galli, Carlo
IR  - Bertazzoli E
FIR - Bertazzoli, Emanuela
IR  - Lunghi G
FIR - Lunghi, Giovanna
IR  - Matteelli A
FIR - Matteelli, Alberto
IR  - Tisi G
FIR - Tisi, Giancarlo
IR  - Zanchetta N
FIR - Zanchetta, Nadia
IR  - Zuccotti G
FIR - Zuccotti, Gianvincenzo
EDAT- 2012/06/01 06:00
MHDA- 2013/05/25 06:00
CRDT- 2012/06/01 06:00
PHST- 2012/05/10 00:00 [received]
PHST- 2012/05/14 00:00 [accepted]
PHST- 2012/06/01 06:00 [entrez]
PHST- 2012/06/01 06:00 [pubmed]
PHST- 2013/05/25 06:00 [medline]
AID - 1471-2407-12-204 [pii]
AID - 10.1186/1471-2407-12-204 [doi]
PST - epublish
SO  - BMC Cancer. 2012 May 30;12:204. doi: 10.1186/1471-2407-12-204.