Australian leader in clinical services conducts retrospective study

Photo by Robina Weermeijer

This observational study is developed by Western Sydney Local Health District.

The study title is identified as A Retrospective Study of Clinical Outcomes and Liver-related Toxicity of Patients With Lung Cancer Treated With Immune-checkpoint Inhibitors.

This study aims to establish clinical risk factors that can predict the occurrence of liver immune-related adverse events in patients with advanced lung cancer treated with immune-checkpoint inhibitors. Such predictors may assist in the stratification of patients based on their risk for development liver toxicity as a result of immunotherapy, allowing early cessation/modification of treatment prior to the development of severe adverse reactions. In addition, this retrospective study will aim to determine the significance of pre-existing liver damage on the development of liver adverse events as well as establish a timeline defining the development of adverse events in the liver.

The first participant was enrolled in a clinical study on January 7, 2020.

It was stated that there are such primary outcome measures:

1. Incidence of immune-mediated hepatitis.

2. Baseline risk factors significantly correlated with hepatic immune-related adverse events. Blood test results, BMI, FibroScan data will be correlated with the development of liver toxicity

Patients must meet the following criteria:

• Advanced lung cancer (stage IV);
• Treatment - immune-checkpoint inhibitors or chemotherapy;
• Data is fully available for the whole period of observation.

The list of locations:

Westmead Hospital, Sydney, New South Wales, Australia, 2145

Blacktown Hospital, Sydney, New South Wales, Australia, 2148

Nepean Hospital, Sydney, New South Wales, Australia, 2747

University of Western Sydney is the collaborator in this study.

Contact details and further information: https://ichgcp.net/clinical-trials-registry/NCT04595734