Data Collection for Cancer Immunotherapy Side Effects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather data and samples from patients who have experienced side effects from immunotherapy treatments. The goal is to help researchers understand and find ways to better predict, prevent, and treat these side effects in the future. Participants will provide tissue and blood samples (biospecimen collection), and researchers will review their medical records over a year (medical chart review). Patients who have experienced serious side effects after starting immunotherapy, such as skin or joint issues, rare infections, or rapid disease progression, might find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future immunotherapy treatments.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover crucial insights into the side effects of immunotherapy, an increasingly popular cancer treatment. Unlike typical treatments for managing side effects, which often involve medication to alleviate symptoms, this study collects biospecimens like tissue, blood, and sometimes stool samples. By analyzing these samples and reviewing medical records, researchers hope to understand why severe immune-related adverse events occur and how they can be better managed or predicted in the future.
Who Is on the Research Team?
David Kozono, MD, PhD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection
Collection of tissue and blood samples at the time of registration and at 1 month after registration
Follow-up
Patients' medical records are reviewed for up to 1 year to monitor for immune-related adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Biospecimen Collection
- Medical Chart Review
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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