Actively Recruiting

Age: 18Years +
All Genders
ID04119713

Mechanisms of Immunotoxicology in Cancer Patients

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-01-08

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how cancer treatment with immune checkpoint inhibitors can lead to the development of autoimmunity. The goal is to understand the genetic and immune system factors that cause some cancer patients receiving checkpoint inhibitors to develop immune-related adverse events (irAEs). This observational study aims to enroll at least 300 patients who are prescribed checkpoint inhibitors to explore these effects in detail. Participants will provide blood and serum samples at enrollment and during scheduled times when receiving their cancer treatments and routine lab tests. Samples may also be collected if autoimmune symptoms develop. Urine samples may be collected as well. There are no planned treatment interventions in this study; it focuses on collecting biological samples and clinical data to analyze immune system changes and genetics related to treatment. During the study, researchers will collect clinical information from medical records and store coded data securely. They will analyze immune cell types and functions and track the occurrence of autoimmune side effects over six years. The study also aims to facilitate future research collaborations using the established databank of tissues and clinical data. Participants will be involved in providing samples and allowing review of their medical records during this time.

CONDITIONS

Brief Title

Autoimmunity After Checkpoint Blockade

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A diagnosis of cancer and prescription for a checkpoint inhibitor
Not Eligible

You will not qualify if you...

  • Not willing or able to give consent
  • Children under 18 years old
  • History of transplant

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at the time of initial checkpoint inhibitor prescription

Monitoring

Duration - Up to 6 years

Participants provide peripheral blood, serum, and occasionally urine samples at established time points during their routine clinical care and therapeutic infusions. Clinical data are collected from electronic medical records to study immune system features and development of autoimmunity.

Sample collection aligned with routine therapeutic infusions and clinical labs; additional visits if autoimmune symptoms develop

Trial Site Locations

Total: 1 location

1

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

K

Kyra J Sacksith

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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