Understanding autoimmunity in cancer patients treated with immune checkpoint inhibitors
Official title: Mechanisms of Immunotoxicology in Cancer Patients
Run by Abramson Cancer Center at Penn Medicine · NCT04119713 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | February 24, 2020 |
| Main results expected | February 24, 2030 |
| Study ends | February 24, 2030 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT04119713 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with cancer who are being prescribed immune checkpoint inhibitors and can provide informed consent.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Genetic testing for immune disorders
This study is testing how genetic factors affect immune disorders by looking at samples from people already involved in other research, to help improve care and understanding of these conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.