CA209_116 LENS expansion study
Research type
Research Study
Full title
Observational Study Protocol CA209-116\nTREATMENT PATTERNS, OUTCOMES AND RESOURCE USE STUDY FOR ADVANCED STAGE NON-SMALL CELL LUNG CANCER (SQUAMOUS AND NON-SQUAMOUS) IN EUROPE\n
IRAS ID
173734
Contact name
S. Michael Crawford
Contact email
Sponsor organisation
Bristol-Myers Squibb Pharmaceuticals Ltd
Duration of Study in the UK
0 years, 1 months, 25 days
Research summary
For this study to observe treatment patterns, outcomes and resources used for patients who were diagnoses with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) it will collect data from the medical records of patients diagnosed with NSCLC between 01 July 2010 and 30 September 2012 to follow their treatment journey through to today, and whether they are still alive. Part 1 of the study will collect data from the medical records of all patients with this diagnosis treated at up to 40 hospitals across the UK. Each patient’s data will be allocated a number so that it is de-identified or anonymised at the hospital and before the data is sent to the researchers, the key for which is only known by the treating hospital, therefore at no time can the patient be identified. Additionally the researchers will not know from which hospitals the patient’s data has been collected. For Part 2 of the study, a random selection of the anonymised (Part 1) patients will be made and more in depth data will be collected and anonymised before given to the researchers. For Part 3 of the study another randomised selection of the anonymised (Part 1) patients will be made. This time making sure that the more in depth data collected is for an equal numbers of patients with squamous and non-squamous advanced NSCLC (squamous and non-squamous are types of NSCLC) who started 2nd Line of Treatment (LoT). This 2nd LoT is a treatment or therapy regimen which is used after the initial treatment option is deemed to have been tried and either exhausted, no longer works adequately or the tumour has returned. Again, the data collected will be anonymised before given to the researchers.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0667
Date of REC Opinion
4 Dec 2015
REC opinion
Further Information Favourable Opinion