Riesgo de cáncer colorrectal asociado al uso de medicamentos: estudio de casos y controles (IJG-CCR-2015)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/12698
• EU PAS number:
  EUPAS12697
• Study ID:
  12698
• Official title and acronym:
  Riesgo de cáncer colorrectal asociado al uso de medicamentos: estudio de casos y controles (IJG-CCR-2015)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Colorectal 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.
• Study status:
  Ongoing

Research institution and networks

Institutions

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Contact details

Maria Angeles Quijada Manuitt

Study contact

[e-mail]

Maria Angeles Quijada Manuitt

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 01/09/2015

Actual: 27/11/2015

Data collection

Planned: 02/02/2015

Actual: 01/03/2016

Start date of data analysis

Planned: 01/04/2016

Date of final study report

Planned: 01/11/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bioiberica

Study protocol

Initial protocol

Protocolo CCR v04 08-03

Regulatory

• Was the study required by a regulatory body?:
  No