240 Participants Needed

Data Collection for Cancer Immunotherapy Side Effects

Recruiting at 636 trial locations
DK
Overseen ByDavid Kozono, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Alliance for Clinical Trials in Oncology
Must be taking: Immuno-oncology therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

DK

David Kozono, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Received a regimen containing one or more immuno-oncology therapeutics
One or more serious (Grade 3-4) AEs that are likely immune-related
One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Sample Collection

Collection of tissue and blood samples at the time of registration and at 1 month after registration

1 month
2 visits (in-person)

Follow-up

Patients' medical records are reviewed for up to 1 year to monitor for immune-related adverse events

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Biospecimen Collection
  • Medical Chart Review
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Observational (biospecimen collection, medical record review)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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