Understanding autoimmunity in cancer patients treated with immune checkpoint inhibitors
Mechanisms of Immunotoxicology in Cancer Patients
This study looks at how cancer treatments that boost the immune system might cause some patients to develop autoimmune issues, by collecting samples and data from those receiving these therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04119713 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how cancer treatment with immune checkpoint inhibitors can lead to the development of autoimmunity in some patients. It will enroll at least 300 cancer patients who are prescribed these therapies and collect peripheral blood, serum, and urine samples at various time points, including when autoimmune symptoms arise. The study will analyze genetic and immune system features to identify factors associated with immune-related adverse events. There will be no interventions, and clinical data will be gathered from electronic medical records.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with cancer who are being prescribed immune checkpoint inhibitors and can provide informed consent.
Not a fit: Patients under 18 years old, those with a history of transplant, or individuals unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify genetic and immune markers that predict autoimmunity in cancer patients, potentially leading to better management strategies.
How similar studies have performed: While the study focuses on a specific aspect of immune checkpoint inhibitors, similar studies have shown that understanding immune responses can lead to improved patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of cancer and prescription for a checkpoint inhibitor Exclusion Criteria: * Any subjects not willing or able to give consent * Children under the age of 18 * A history of transplant
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania - Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sokratis Apostolidis, MD — University of Pennsylvania
- Study coordinator: Kyra J Sacksith
- Email: kyra.sacksith@pennmedicine.upenn.edu
- Phone: 215-898-9339
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.