Cancer Clinical Trial
Official title:
Mechanisms of Immunotoxicology in Cancer Patients
NCT number | NCT04119713 |
Other study ID # | 832823 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 24, 2020 |
Est. completion date | June 30, 2026 |
The purpose of this study is to better understand how the treatment of cancer with immune checkpoint inhibitors (ICI) leads to the development of autoimmunity. Specifically, we wish to understand the genetics and immune system features that cause a subset of cancer patients treated with checkpoint inhibitor therapy to develop an immune-related adverse event (irAE).
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The phenotype and function of peripheral blood cells (i.e., CD4+ T cells, CD8+ T cells, B cells, myeloid cells) characteristic to patients receiving checkpoint inhibitor therapy. | The phenotypic analysis will include multiple surface markers that define populations of cells, including activated, memory, and regulatory populations. Cells will also be activated to determine which cytokines are produced. | 3 years | |
Primary | The prevalence of immune-related adverse events (irAEs) that complicate checkpoint inhibitor therapy. | This is a pilot analysis to better understand how the treatment of cancer with immune checkpoint inhibitors leads to the development of autoimmunity in a subset of cancer patients. | 3 years | |
Secondary | The number of future research studies and/or collaborations resulting directly from the databank of tissues and other relevant clinical information that will be established. | To facilitate collaborations between research groups from diverse disciplines that enables rapid translation of ongoing and future basic research findings that leads to individualized, or personalized care for patients receiving immunotherapies. | 3 years |
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