Status: Ongoing First registered on: 08/03/2016
Last updated on: 08/03/2016
1. Study identification
EU PAS Register NumberEUPAS12697
Official titleRiesgo de cáncer colorrectal asociado al uso de medicamentos: estudio de casos y controles
Study title acronymIJG-CCR-2015
Study typeObservational study
Brief description of the studyColorectal cancer (CRC) is a heterogeneous disease. It has been reported that some chronic exposure to drugs can modulate the risk of CRC, and it has been studied possible preventive measures to detect if some exposures may increase the risk of CRC. Most current information comes from studies in Anglo-Saxon or northern European countries. Our population characteristics (lower cardiovascular risk and different diet) may determine baseline differences in risk. It is important to see if there are changes CRC risk associated with drugs already described in other populations, whose dietary characteristics are also observed and cardiovascular risk are different. It is therefore proposed to study CRC risk associated with drug exposures described as protective or risk factors. In addition, the retrospective study of chronic exposure to a broad spectrum of drugs in an affected population of CRC could allow associations identification previously undescribed. These associations could be evaluated in detail in order to generate new hypotheses. This case-control study assesses the association between CRC and chronic exposure to drugs.It will be obtain data from the Information System for the Improvement of Research in Primary Care (clinical variables, laboratory and prescribed medication) in 2010-2015, including more than 5,000 cases with the diagnosis of CRC and its controls. We will analyze CRC risk associated with chronic exposure to drugs adjusted by risk factors by logistic regression. We will analyze dose-response drugs associations showing statistical significance, in terms of duration of exposure and cumulative dose relationship. Possible drug interactions and potential effect modifiers exhibitions will be explored.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 belongsIDIAPJGol
Department/Research groupMedicine research unit
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Dr
Last name Quijada Manuitt
First name Maria Angeles
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/09/201527/11/2015
Start date of data collection02/02/201501/03/2016
Start date of data analysis01/04/2016
Date of interim report, if expected
Date of final study report01/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBioiberica100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Quijada Manuitt
First name Maria Angeles
Address line 1Gran Via Corts Catalanes, 587
Address line 2 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain
Phone number (incl. country code)34-93-4824559 
Alternative phone number 
Fax number (incl. country code) 
Email address aquijada@idiapjgol.org
Public Enquiries
Title Dr 
Last name Quijada Manuitt 
First name Maria Angeles 
Address line 1Gran Via Corts Catalanes, 587 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain 
Phone number (incl. country code)34-93-4824559 
Alternative phone number 
Fax number (incl. country code) 
Email address aquijada@idiapjgol.org 
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