Commonly prescribed drugs and association with breast, colorectal and lung cancer progression: a nested case-control study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27410
• EU PAS number:
  EUPAS1863
• Study ID:
  27410
• Official title and acronym:
  Commonly prescribed drugs and association with breast, colorectal and lung cancer progression: a nested case-control study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  There is growing evidence that commonly prescribed cardiovascular medications such as betablockers, angiotensin converting enzyme inhibitors and angiotensin II type I receptor blockers, pain relief medications such as nonsteroidal antiinflammatory drugs and aspirin and bisphosphonates (drugs that prevent loss of bone mass), may have unintended positive consequences in relation to the prevention of cancer metastasis and recurrence. To date however, there have been very few epidemiological studies which have investigated this association. Since 2008 in Northern Ireland (NI), prescriptions given to any patient registered with a GP have incorporated a 2D barcode. Each barcode stores information pertaining to the patient, practice and medication to which the prescription pertains. When prescriptions are dispensed at community pharmacies the scripts are sent to the Business Services Organisation (BSO) were the 2D barcode is scanned and the information entered into an Enhanced Prescribing Database (EPD). EPD is therefore a central database of prescribed and dispensed medications for approximately 1.9 million patients registered with a GP in NI. The Northern Ireland Cancer Registry (NICR) was established in 1994 and uses an automated computer system, fed with patient data from hospital and histopathology records and death notifications from a variety of sources, to collate information on new diagnoses of cancer in the province.This study will link tumour staging and treatment data collated from the NICR on patients diagnosed with primary breast, colorectal and lung cancer between 1st July 2008 and 31st Dec 2011 (inclusive) to commonly prescribed medications held on these patients in the BSO; each patient's individual Health & Care number will be used to link the records in each dataset. This study will help identify the class and dose of drug(s) most likely to influence cancer progression and recurrence and assess their effects on cancer specific mortality.
• Study status:
  Planned

Research institutions and networks

Institutions

Queen's University Belfast

Study timelines

Date when funding contract was signed

Planned: 01/09/2011

Actual: 03/10/2011

Study start date

Planned: 31/10/2011

Data analysis start date

Planned: 01/01/2013

Date of interim report, if expected

Planned: 31/07/2012

Date of final study report

Planned: 20/12/2020

Sources of funding

Other

More details on funding

Queen's University Belfast

Study protocol

Initial protocol

Commonly prescribed drugs and association with cancer progression_protocol

Updated protocol

NICR_EPD_Protocol_v1.2

Regulatory

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