Study identification

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 institutions and networks

Institutions

Contact details

Maria Angeles Quijada Manuitt

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bioiberica
Regulatory

Was the study required by a regulatory body?

No