Clinical trial NCT04119713: Autoimmunity After Checkpoint Blockade
Official title: Mechanisms of Immunotoxicology in Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmunity
Cancer
Immunotoxicity
Oncology
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are able to consent to the study and are identified by their physician or a clinical coordinator to receive an immune checkpoint inhibitor for the treatment of cancer.

Brief summary: 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).

Detailed description: The goal of this study is to understand how the treatment of cancer with checkpoint inhibitors leads to the development of autoimmunity. Specifically, to understand the genetics and immune system features that cause a subset of cancer patients treated with checkpoint inhibitors to develop autoimmunity. At least 300 patients will be enrolled when they are initially prescribed any checkpoint inhibitor. Peripheral blood and serum from patients when they enroll and examine the genetics, serum factors, and phenotype of the immune system. There is no planned intervention. Subjects will be asked to provide peripheral blood and serum at established time points when they are getting therapeutic infusions and routine clinical labs, as well as, at the time they develop any autoimmune symptoms. Urine may also be collected at the time of enrollment, standard study visits, and/or at the time of an autoimmune complication. Inclusion criteria include a diagnosis of cancer, prescription for a checkpoint inhibitor, and fluency in English. Exclusion criteria include any subjects not willing or able to give consent, children under the age of 18, and history of transplant. There will not be any interventions. Clinical data will be extracted from electronic medical records. Coded data will be stored in a REDCap database. PHI and study key stored at UPenn on a password-protected database on an encrypted drive that is institutionally secured and managed by the University of Pennsylvania.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 3 years
measure: The prevalence of immune-related adverse events (irAEs) that complicate checkpoint inhibitor therapy.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania - Abramson Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sokratis Apostolidis, MD
role: PRINCIPAL_INVESTIGATOR
References: