Status: Finalised First registered on: 08/08/2020
Last updated on: 08/08/2020
1. Study identification
EU PAS Register NumberEUPAS36692
Official titleFirst-line anticancer drugs in patients with advanced, primary Non-Small Cell Lung Cancer: drug-utilization and effectiveness studies from Tuscany Region healthcare database
Study title acronym
Study typeObservational study
Brief description of the studyThe aim of the project is evaluate drug utilization and the effectiveness of first-line anticancer therapies approved for the treatment of advanced, non-resectable, NSCLC patients between 2009 and 2019 in the Tuscany population. Two studies will be thus performed on a cohort of patients with not-resectable, primary NSCLC: a drugs utilization study and a survival study. For the purpose of this study two different, already pseudo-anonymized, data sources will be used: pathology registry and administrative healthcare data of the Tuscany region.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Andrea
First name Spini
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

ARS
University of Siena, Department of Life Sciences and Departement of Medicine, Surgery and Neuroscience, Siena, Via Aldo Moro 2
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/08/202008/08/2020
Start date of data collection15/08/202008/08/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/202008/08/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherNot funded100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Andrea
First name Spini
Address line 1146 Rue Leo Saignat
Address line 2Bordeaux PharmacoEpi, INSERM CIC1401 
Address line 3Département de pharmacologie, Université de Bordeaux, 146 rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)00393276151702 
Alternative phone number 
Fax number (incl. country code) 
Email address andrea.spini@u-bordeaux.fr
Public Enquiries
Title Dr 
Last name Andrea 
First name Spini 
Address line 1146 Rue Leo Saignat 
Address line 2Bordeaux PharmacoEpi, INSERM CIC1401 
Address line 3Département de pharmacologie, Université de Bordeaux, 146 rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)00393276151702 
Alternative phone number 
Fax number (incl. country code) 
Email address andrea.spini@u-bordeaux.fr 
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