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Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity

This is a prospective cohort study aiming to establish clinical and biological risk factors of immune-checkpoint inhibitors (ICIs) mediated toxicity. ICIs have recently revolutionized cancer treatment and already considered as a new standard of care for lung cancer, renal carcinoma, melanoma and hepatocellular carcinoma. However, the variability in response rates and high incidence of specific immune-related adverse events (irAEs) are the major barrier for implementing ICIs as universal anticancer treatment. With this regard, it is of extreme importance to discover biomarkers of irAEs development and responsible mechanisms which will overall markedly enhance cancer immunotherapy. This study will recruit patients treated at Oncology clinics of Blacktown and Westmead Public Hospitals of the Western Sydney Local Health District. The particular point of interest will be non-coding RNA (ncRNA) which have been shown to modulate the expression of immune checkpoints. Moreover, specific ncRNAs are significantly associated with survival rates of lung cancer patients treated with nivolumab, albeit without an established mechanism. Investigators aim to collect patient's peripheral blood (30 ml) which will be further used for extracting total RNA and immune cells. RNA sequencing and flow cytometry will be major research tools of this project. The clinicopathological data will be collected via Cerner and Aria electronic systems of medical records. All data will be encrypted and stored at REDCap database with access provided only to study investigators.

Start: December 2020