Real World Outcomes of Patients with mCRC
Research type
Research Study
Full title
Estimating treatment patterns and health outcomes in adults with metastatic colorectal cancer (mCRC) with or without high microsatellite instability (MSI): A retrospective real-world study
IRAS ID
234519
Contact name
Kai-Keen Shiu
Contact email
Sponsor organisation
Bristol-Myers Squibb Pharmaceuticals Ltd.
Duration of Study in the UK
0 years, 4 months, 27 days
Research summary
Colorectal cancer (CRC) is the third most common cancer for males and females and accounted for 34,729 cases in England in 2015. Patients with the most severe staged disease (stage 4 CRC) have a one-year survival rate of just 41.2%.\n\nMany cases of CRC are associated with molecular markers. One such molecular maker is microsatellite instability (MSI; a change in the number of DNA repeat sequences), which is a molecular signature of deficient mismatch repair (dMMR) in tumour DNA, and is found to occur in around 15% of CRC. There is evidence to suggest that patients with dMMR/MSI and other mutations, such as KRAS and BRAF mutations, may have a different response to systemic therapies used to treat metastatic colorectal cancer (mCRC). However, from the UK perspective, real world evidence of the effectiveness of existing treatments in patients with differing dMMR/MSI-status is very limited. \n\nWith this in mind, the objective of this study is to generate real world evidence describing the outcomes of patients with mCRC receiving systemic therapies in the UK, with particular emphasis on comparisons between patients with differing dMMR/MSI-status.\n\nThe study will take place in two hospital sites in England. Clinical data will be sourced directly from patient medical records for primary diagnoses of mCRC recorded from 01 January 2011 – 31 December 2016, defined as the study period. The study period was chosen to provide a contemporaneous dataset of patients with up to five years follow up data. \n\nData collection will be entirely retrospective and does not involve direct patient contact. To ensure patient confidentiality, all data will be anonymised during data collection and before data delivery to the CRO. The sponsor and CRO will only receive anonymised data and will not have access to patient identifiable information.\n\nThe study is sponsored by Bristol-Myers Squibb Pharmaceuticals Ltd.\n
REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0107
Date of REC Opinion
12 Oct 2017
REC opinion
Favourable Opinion