Identifying risk factors for immune-checkpoint inhibitor related toxicities
Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
This study is trying to find out what factors might lead to side effects in patients with cancer who are being treated with immune-checkpoint inhibitors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Western Sydney Local Health District Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Sydney, New South Wales and 1 other locations) |
| Trial ID | NCT04631731 on ClinicalTrials.gov |
What this trial studies
This study investigates the risk factors associated with liver, gastrointestinal, endocrine, and skin toxicities in patients receiving immune-checkpoint inhibitors for various cancers. It is a prospective multicenter cohort study that enrolls patients scheduled for different treatment regimens involving PD1/L1 inhibitors and other therapies. Data will be collected longitudinally, including demographic information, medical history, and biological samples, to better understand the adverse effects of these treatments. The study involves collaboration among oncologists, gastroenterologists, immunologists, and basic scientists from several institutions in New South Wales.
Who should consider this trial
Good fit: Ideal candidates are patients with stage III-IV solid malignant tumors who are scheduled to receive immune-checkpoint inhibitor therapies.
Not a fit: Patients unable to provide informed consent or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and prevention of toxicities associated with immune-checkpoint inhibitors, enhancing patient safety and treatment outcomes.
How similar studies have performed: Other studies have shown success in identifying risk factors for treatment-related toxicities, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study * Solid malignant tumour (stage III-IV) * Treated with ICI-based therapeutic regimens Exclusion Criteria: * Inability to give written informed consent * Patients with a cognitive impairment, an intellectual disability or a mental condition that will interfere with the patient's ability to understand the requirements of the study
Where this trial is running
Sydney, New South Wales and 1 other locations
- Westmead Hospital — Sydney, New South Wales, Australia (Recruiting)
- Blacktown Mt Druitt Hospital — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Golo Ahlenstiel, Professor — Western Sydney Local Health District
- Study coordinator: Dmitrii Shek, Dr
- Email: Dmitri.Shek@health.nsw.gov.au
- Phone: +61 412 035 533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.