Predictors of Immune Related Adverse Events from the use of the Immunotherapy in Patients with Cancer

Not Applicable

Recruiting

• Conditions: Solid Malignancies where patients are receiving immune checkpoint inhibitors - either alone or in combination with other anti-cancer agents; Cancer - Any cancer

• Registration Number: ACTRN12621001146886
• Lead Sponsor: Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-25
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All patients with histologically or cytologically confirmed solid organ malignancies starting immune checkpoint inhibitors alone or in combination with chemotherapy

Patients receiving treatment in either the adjuvant or metastatic settings

Age >= 18 years

Ability to provide informed consent for the study procedures and data collection

Willingness and ability to comply with the study requirements

Signed, written informed consent

Exclusion Criteria

Patients with prior exposure to immune checkpoint inhibitors

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T-cell repertoire using T cell receptor sequencing <br>[T cell repertoire at baseline, on bloods conducted before commencement of cycle 2, on bloods before commencement of cycle 3 and at the onset of a grade 2 or greater immune related adverse event<br>];Auto-antibodies using line blots[Auto-antibodies at baseline, on bloods conducted before commencement of cycle 2 and on bloods before commencement of cycle 3 and at the onset of a grade 2 or greater immune related adverse event]