ONE-RCC
Research type
Research Study
Full title
PATIENT REPORTED OUTCOMES AND TREATMENT EXPERIENCES IN RENAL CELL CARCINOMA (ONE-RCC)
IRAS ID
278846
Contact name
Omi Parikh
Contact email
Sponsor organisation
Bristol-Myers Squibb Pharmaceuticals Ltd.
Clinicaltrials.gov Identifier
44407, NIHR CPMS ID; to follow, ClinicalTrials.gov
Duration of Study in the UK
5 years, 0 months, 2 days
Research summary
This is a multi-country, multi-site, observational, ambispective (retrospective and prospective) study to observe the real-world clinical and humanistic outcomes for patients with advanced Renal Cell Carcinoma (aRCC) initiating 1st Line of Treatment (1LOT) in the US, CA, France, Germany, Italy, Spain, and the UK? It does not have a medicinal product or device. Eligible patients are those who initiated 1LOT between 1st January 2018 and 31st December 2019, and for which retrospective long-term chart review data will be collected, and Cohort 2 will include patients about to initiate 1LOT at study launch and for whom chart review and patients survey will be captured over a 3-year period. The study will be conducted in the UK in NHS hospitals that treat patients with aRCC and have capacity to fulfil the study requirements. Collection of this data, including the patient surveys, into one central repository will permit assessment and analysis of treatment responses, patient experiences and outcomes for patients with aRCC.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0129
Date of REC Opinion
14 May 2020
REC opinion
Further Information Favourable Opinion