Benign Prostate Hyperplasia Clinical Trial
Official title:
Evaluation of the Potential Association Between 5α-reductase Inhibitors Prescription and Occurrence of High Grade Prostate Cancers
This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).
Identification process will be retrospective and prospective using medico-administrative data
from all pathology laboratory registries in Brittany and drug reimbursement files for
patients living in Brittany, France.
An extraction from drug reimbursement files of French health reimbursement agency (CNAM-TS)
for patients living in Brittany, France will be performed on the following request:
reimbursement of any pharmacologic treatment patented for symptomatic benign hyperplasia
between January 1st 2010 and December 31st 2011, and no diagnosis of prostate cancer before
December 31st, 2011. This extraction has to be done in 2013 to catch data as far as 2010 and
will encompass health reimbursement for prostate examination. A second extraction will be
done in 2014 to complete data from the end of 2013.
Secondly, identification of patients will use pathology laboratory registries, based on code
for prostate examination (prostate biopsy, prostatectomy or prostate resection); involvement
of all pathology laboratories in Brittany ensures completeness of collection of prostate
examination results for the study period (January 1st, 2012 to December 31st, 2013). A list
of patients will be recorded at each pathology laboratory level with date of birth, date of
prostate examination, type of exam, results with Gleason score along with a study number on
electronic file.
By January 2014, link to reimbursement file (that is data on all reimbursement within 3
years: 2009 to 2011 previously extracted from the French health reimbursement agency) will be
done thanks to three key variables (date of birth, date of prostate examination,
identification of pathology laboratory) and all data from all centers will set up into one
global file.
This design will allow evaluation of association between 5-ARI and either high grade prostate
cancer or low grade prostate as opposite association could be observed. In addition this
design focuses on the target population, i.e. patients with symptomatic benign prostate
hyperplasia, identified through reimbursement of drugs patented for symptomatic benign
prostate hyperplasia.
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