Advanced Renal Cell Carcinoma (aRCC) Study in the US, Europe
Research type
Research Study
Full title
TREATMENT PATTERNS, OUTCOMES, RESOURCE USE AND PATIENT\nREPORTED OUTCOMES (PRO) / QUALITY OF LIFE (QOL) STUDY FOR\nADVANCED RENAL CELL CARCINOMA (aRCC) IN THE US, EUROPE, BRAZIL\nAND CANADA
IRAS ID
185334
Contact name
Nicola Miles
Contact email
Duration of Study in the UK
Publication of this data is currently deferred.
Research summary
For this study to observe treatment patterns, outcomes and resources used for patients who were diagnosed with advanced renal cell carcinoma (aRCC) it will collect data from the medical records of patients diagnosed with aRCC and will follow their treatment journey through to their most recent visit. Doctors at up to 40 hospitals across the UK will be invited to participate. Part 1A of the study will collect data on all patients diagnosed with aRCC between 01 January 2013 and 31 December 2015 who have been treated at the study site, whether deceased or alive. Part IB will provide on all their patients diagnosed with aRCC between 01 January 2013 and 31 December 2015 who have been treated at the study site, who are alive at the time of collecting the data. 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 patients (based on Part IA) 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 1A) patients will be made. This time making sure that the more in depth data collected is for patients 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. Part IV will be based on part IB to select patients who are alive and are currently receiving 1st line therapy to receive a patient reported outcome / Quality of life Survey.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0240
Date of REC Opinion
10 Aug 2016
REC opinion
Further Information Favourable Opinion