Study identification

PURI

https://redirect.ema.europa.eu/resource/7212

EU PAS number

EUPAS7211

Study ID

7212

Official title and acronym

Translating basic science into improved patient outcomes in ovarian cancer: an Ireland-UK collaboration investigating common pharmacological exposures and tumour characteristics, recurrence, survival and mortality (Effects of Pharmacological exp. on Ovarian Cancer)

DARWIN EU® study

No

Study countries

Ireland
United Kingdom

Study description

Almost 250,000 ovarian cancers are diagnosed worldwide each year. Incidence rates are high in northern Europe, including in Ireland and the UK. These countries have among the highest ovarian cancer mortality rates in the world. The relatively young average age and advanced stage at diagnosis, mean that ovarian cancer is a major burden. Lab-based research suggests that various commonly-used drugs (statins, beta-blockers and NSAIDs) might have potent anti-tumour effects in ovarian cancer. We will combine estimates from cancer registry linked, pharmacoepidemiology databases from Ireland (NCRI/PCRS), Northern Ireland (NICR/EPD) and Great Britain (CPRD/NCDR), to investigate associations between exposure to these three drug groups and ovarian cancer presentation, progression and outcomes. There are three outcomes of interest: (A) associations between pre-diagnosis drug exposure and stage at diagnosis, (B) associations between exposure to drugs and disease recurrence and (C) associations between exposure to drugs and cancer related mortality. Analysis of stage will use a nested case-control design and be performed using conditional logistic regression. Analyses of other outcomes will use a retrospective cohort design to investigate associations between pre- and post-diagnosis exposure. Cox proportional hazards models, with adjustment for known confounders will be used and the lagged time-varying covariate approach will be used to evaluate post-diagnosis exposure. Cohort estimates will be combined in a prospective meta-analysis.

Study status

Ongoing
Research institution and networks

Institutions

Queen's University Belfast Belfast, Northern Ireland (UK)

Contact details

Sharp Linda

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Health Research Board, Ireland
Study protocol
Initial protocol
English (731.9 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No