CAncer Risk and INsulin analoGues (CARING) project

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11823
• EU PAS number:
  EUPAS5383
• Study ID:
  11823
• Official title and acronym:
  CAncer Risk and INsulin analoGues (CARING) project
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Netherlands

  Norway

  Sweden
• Study description:
  The CARING (CAncer Risk and INsulin analoGues) project will obtain precise data on the incidence of cancer in diabetic patients and determine any link with use of various insulin and insulin analogues. The study will utilise high quality prescription databases and other national data sources, integrated at European level with advanced methods of harmonising data. The study will take into account potential confounders. The project aims to determine the influence of drug dose on risk, and through a risk model, identify predictors of cancer for insulin users. A review of published evidence combined with a study of tumour characteristics and gene expression in breast cancer tumour collections will aid understanding of potential mechanisms of cancer initiation and/or promotion by insulin.
• Study status:
  Finalised

Research institution and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Tampere University Hospital

Finland

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Department of Chronic Diseases, Pharmacoepidemiologic Research Group, Norwegian Institute of Public Health (NIPH)

Norway

Aarhus University Hospital

Helsinki University Hospital (HYKS)

Aarhus University Hospital Aarhus, Denmark, University of Tampere Tampere, Finland, University of Helsinki Helsinki, Finland, Netherlands Cancer Institute Amsterdam, Netherlands

Networks

CAncer Risk and INsulin analoGues (CARING)

Denmark

Finland

Netherlands

Norway

Sweden

Study timelines

Date when funding contract was signed

Planned: 18/07/2011

Actual: 18/07/2011

Study start date

Planned: 01/11/2011

Actual: 01/11/2011

Data analysis start date

Planned: 01/08/2014

Actual: 01/08/2014

Date of final study report

Planned: 21/12/2015

Actual: 21/12/2015

Sources of funding

EU institutional research programme

More details on funding

FP7 HEALTH.2011.4.2-2

Study protocol

Initial protocol

CARING Common Protocol 3.0

Updated protocol

CARING Common Protocol 3.3

Regulatory

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