Treatment patterns of SCLC patients in Europe

• Research type

  Research Study

• Full title

  Treatment patterns among patients with advanced Small-Cell Lung Cancer (SCLC) in Europe

• IRAS ID

  228819

• Contact name

  Fiona Blackhall

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Clinicaltrials.gov Identifier

  CANC35069, NIHR

• Duration of Study in the UK

  0 years, 5 months, 28 days

• Research summary

  Small cell lung cancer (SCLC) represents around 15% of all lung cancers and is often staged as limited-stage disease (LD) and extensive-stage disease (ED). At the time of diagnosis, the majority of patients will present with ED. Despite treatment advances, and even with the best available therapy, most patients with SCLC have poor outcomes. Patients with SCLC tend to develop distant metastases, and local treatments such as surgery have only a limited effect in terms of survival.

  This real-world, observational retrospective study conducted in four European countries (France, Germany, Italy, United Kingdom (UK)) aims to get representative evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease. The study investigators will be oncologists who routinely manage SCLC patients within their clinical practice.

  Within the UK, a target sample of 316 patients meeting the study eligibility criteria will be recruited from about 13 different NHS hospital sites where the physician or member of the research team will collect data from their medical records and transfer into an electronic case report form (eCRF) questionnaire. Patients will be screened for eligibility by the research staff by looking back in their medical records and patients meeting the study criteria will be selected.
  
  Patients will be categorised into three groups depending on their stage of SCLC and which line of treatment they are on. Follow-up will continue from either the date of diagnosis or the date they began second line treatment up until the date of their last medical record or death, whichever comes first. All data will be collected retrospectively.

  Data collection is expected to last approximately 21 weeks for the UK.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  17/YH/0368

• Date of REC Opinion

  24 Oct 2017

• REC opinion

  Favourable Opinion