The diagnostic accuracy of digital PCR, ARMS and NGS for detecting KRAS mutation in cell-free DNA of patients with colorectal cancer

Cetuximab and panitumumab have been used clinically to treat metastatic colorectal cancer for more than 15 years. Before the treatment is given, it is required to determine the KRAS mutation status since it would lead to drug resistance. Tumor tissue sample is traditionally used for cancer genotyping. In recent years, liquid biopsy sample has been intensively investigated as a surrogate for tumor tissue sample due to its non-invasiveness and better presentation of tumor heterogeneity. The aim of this study is to systematically summarize the accuracy of KRAS mutation measurement in colorectal cancer using cell-free DNA in liquid biopsy samples, with tumor tissue sample as reference (gold standard). Methods and analysis: We will search literatures in the following databases: Pubmed, Embase, and Cochrane Library. Systemic review and meta-analysis will be performed to summarize the accuracy of KRAS mutation measurement in colorectal cancer using liquid biopsy sample, and subgroup analysis will be performed on different testing platforms, and on metastatic and non-metastatic colorectal cancer. Timeline: This study will start on June 1, 2020, and is expected to be finished by November 1, 2020. Ethics and dissemination: Ethical approval will not be required since the data obtained and analyzed in this study will not be on individual patients. Study results will be disseminated as an official publication in a peer-reviewed journal. Registration: PROSPERO CRD42020176682