ASPIrin use and colorectal CANcer risk (ASPICAN)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24908
• EU PAS number:
  EUPAS24907
• Study ID:
  24908
• Official title and acronym:
  ASPIrin use and colorectal CANcer risk (ASPICAN)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Aspirin 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

ISPRO Florence, Italy

Study timelines

Date when funding contract was signed

Actual: 09/01/2017

Study start date

Actual: 10/07/2017

Date of final study report

Planned: 04/03/2019

Sources of funding

Other

More details on funding

ARS and ISPRO

Study protocol

Initial protocol

ASPICAN_ENCEPP Protocol_v1

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable