Status: Finalised First registered on: 20/07/2018
Last updated on: 25/07/2018
1. Study identification
EU PAS Register NumberEUPAS24907
Official titleASPIrin use and colorectal CANcer risk
Study title acronymASPICAN
Study typeObservational study
Brief description of the studyAspirin has been associated with a reduced risk of Colorectal cancer (CRC) and its use for the primary prevention of CRC has been debated for a long time. Recently, the United States Preventive Services Task Force recommended low-dose aspirin use for the primary prevention of cardiovascular diseases (CVD) and CRC among “adults [aged] 50 to 59 years who have a 10% or greater 10-year CVD risk [...]". To date, different observational studies investigated this topic considering different patients populations and study designs to minimize the effect of possible residual and/or uncontrolled confounders with respect to the association between LDA use and CRC. To the best of our knowledge, no study have addressed this issue within a population of patients for which LDA use should be expected, i.e. in secondary cardiovascular prevention. Using regional administrative data from Tuscany, Italy (>3.5 million inhabithants), we will performe a case-control study nested in a cohort of patients with first occurrence of a CVD between 2005-2010 (cohort entry). The 5th anniversary after the index hospital discharge will be the start of the period at risk for the occurrence of CRC. Each patient will be followed until the occurrence of the study outcome or any other censoring event (death, exit from the database, other cancer types, 31 December 2016) whichever came first. The date of occurrence of CRC will be the case index date. Per each case, up to 5 controls matched by sex, age and year of cohort entry. According to utilization of low-dose aspirin (LDA) prior to index date, we will define “ever use” as 2 or more LDA dispensings and “nonuse” as fewer than 2 dispensings. We will than model the exposure within the ever use category according to recency, continuity, duration, prescribed daily dose and average daily amount of LDA received during follow-up. Multivariable logistic regression will be used to estimate Odds Ratio and 95% IC intervals for the association between CRC and LDA.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsARS
Department/Research groupOsservatorio di Epidemiologia
Organisation/affiliationAgenzia regionale di sanità della Toscana (ARS)
Website/Homepagehttp://www.ars.toscana.it/it/
Details of (Primary) lead investigator
Title Dr
Last name Ventura
First name Leonardo
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

ARS
ISPRO, Florence, Italy
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/01/2017
Start date of data collection10/07/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report04/03/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyARS and ISPRO100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ventura
First name Leonardo
Address line 1Via delle Oblate 2
Address line 250141 
Address line 3 
CityFlorence 
Postcode50141 
CountryItaly
Phone number (incl. country code)390557972502 
Alternative phone number 
Fax number (incl. country code) 
Email address l.ventura@ispro.toscana.it
Public Enquiries
Title Dr 
Last name Ventura 
First name Leonardo 
Address line 1Via delle Oblate 2 
Address line 250141 
Address line 3 
CityFlorence 
Postcode50141 
CountryItaly 
Phone number (incl. country code)390557972502 
Alternative phone number 
Fax number (incl. country code) 
Email address l.ventura@ispro.toscana.it 
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