RecruitingACTRN12621001146886

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

A comprehensive ImmuNe-related adVerse Event (irAE) database associated with immune checkpoint use in SouTh WEst SyDney to investigate mechanisms and impact of adverse effects in patients with cancer.

Sponsor

Western Sydney University

Enrollment

120 participants

Start Date

Apr 28, 2021

Study Type

Observational

Conditions

Solid Malignancies where patients are receiving immune checkpoint inhibitors - either alone or in combination with other anti-cancer agents

Summary

This study is aiming to create an adverse event database to document any negative side effects that people with cancer who are taking specific immunotherapy drugs (immune checkpoint inhibitors) may experience. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with any type of cancer that features solid tumours and you are about to start an immune checkpoint inhibitor therapy alone or in combination with chemotherapy. Study details All participants who choose to enrol in this study will be asked to provide a blood sample once before they start the immunotherapy and then before the second and third cycle of treatment. Participants will also be asked to provide stool and tissue samples before starting treatment and before the second cycle, for biomarker analysis. All participants will be asked to list any side effects/adverse events that they experience while taking the immunotherapy drugs to their usual treating oncologist. It is hoped this research will identify potential biomarkers and clinical features that may predict adverse events related to treatment with immune checkpoint inhibiting drugs that are increasingly being used to treat cancer patients. This information may then be used to improve health outcomes for future cancer patients.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Immunotherapy drugs called immune checkpoint inhibitors have transformed cancer treatment for many patients with solid tumours. However, they can sometimes cause the immune system to attack healthy tissues, leading to side effects that can range from mild rashes to serious inflammation of the lungs, gut, liver, or other organs. Predicting who will experience these side effects before treatment starts could allow doctors to monitor and manage them more proactively. This study is building a database of cancer patients starting immune checkpoint inhibitor therapy and tracking them for side effects throughout treatment. Before and during the first few cycles, blood, stool, and tissue samples will be collected to look for biomarkers — measurable signals in the body — that might predict which patients are most at risk of immune-related side effects. You may be eligible if you are 18 or older, have been diagnosed with a solid tumour cancer, and are about to start treatment with an immune checkpoint inhibitor (either alone or with chemotherapy). You are not eligible if you have already received immune checkpoint inhibitor treatment in the past.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

- Collection of demographic, treatment and disease based factors from review of the patients' medical records. This includes age, sex, co-morbidities, list of medications, date of diagnosis, type of cancer, histopathology, type of treatment, intent of treatment, date treatment was commenced and outcome (disease response, progression or stabilisation). Participants will provide consent for this information to be collected from their medical files. - Collection of blood samples (3x tubes for, 2x EDTA, 1 x serum) for storage and testing at the following time points (baseline i.e. before starting treatment, before the second cycle of treatment with immune checkpoint inhibitors, before the third cycle of treatment with checkpoint inhibitors, at 12 months following commencement of immune checkpoint inhibitor therapy (if still on this) and on development of a grade 2 or greater immune related adverse event at any point from commencement of an immune checkpoint inhibitor - Collection of stool sample at baseline and before second cycle of treatment with immunotherapy - Access to tissue collected at biopsy or cytology before commencement of treatment, where accessible. No additional biopsy will be required. - The overall duration of observation will be 12 months from recruitment.

Locations(2)

Liverpool Hospital - Liverpool

NSW, Australia

Campbelltown Hospital - Campbelltown

NSW, Australia

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ACTRN12621001146886