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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01385436
Date of registration: 24/06/2011
Primary sponsor: University Hospital for Infectious Diseases, Croatia
Public title: Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia HPV-cancer
Scientific title: Pre-vaccination Distribution of Human Papillomavirus (HPV) Genotypes in Patients With High Grade Cervical Squamous Intraepithelial Lesion (HSIL) and Cervical Cancer From Croatia
Date of first enrolment: May 2010
Target sample size: 400
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01385436
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Cross-Sectional  
Countries of recruitment
Croatia
Contacts
Name:   Adriana Vince, MD, PhD
Address: 
Telephone: ++38512826222
Email: avince@bfm.hr
Affiliation: 
Name:   Adriana Vince, MD, PhD
Address: 
Telephone: ++38512826222
Email: avince@bfm.hr
Affiliation: 
Name:   Adriana Vince, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University Hospital for Infectious Diseases Zagreb, Croatia
Key inclusion & exclusion criteria

Inclusion Criteria:

- Women aged 18-65 with a cytological diagnosis of CIN2+cervical lesions from all over
Croatia that are referred to National Reference Center because of HSIL or malignant
cytology findings

Exclusion Criteria:

- Women younger than 18 or older than 65

- Pregnant women



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Cervical Cancer
Intervention(s)
Primary Outcome(s)
Pre-vaccination distribution of HPV genotypes in women with HSIL and invasive cervical carcinoma [Time Frame: two years]
Secondary Outcome(s)
HPV vaccine coverage in Croatia [Time Frame: two years]
Secondary ID(s)
UHID-02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Merck
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