Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
SWOG Cancer Research Network
Summary
This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.
Description
PRIMARY OBJECTIVE: I. To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors. SECONDARY OBJECTIVES: I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy. II. To observe the trajectory of patient-reported quality of life and health preferences over 12 months. III. To…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial * Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration * Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE * Participants must not have received chemothera…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood sample
- OtherQuestionnaire Administration
Complete questionnaires
Locations (849)
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Anchorage Radiation Therapy CenterAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Alaska Women's Cancer CareAnchorage, Alaska
- Anchorage Oncology CentreAnchorage, Alaska