Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects
Purpose
This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.
Condition
- Malignancy
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Received a regimen containing one or more immuno-oncology therapeutics
- Must have experienced one or more of the following:
- 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
- Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO
treatment
** Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
- Hyperprogression. Image submission for patients experiencing hyperprogression
is required. For assistance in determining hyperprogression for purposes of
eligibility, institutions may contact the study chair and submit images for
central review
- Has not previously been registered to this study
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational (biospecimen collection, medical record review) | 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. |
|
Recruiting Locations
Boston, Massachusetts 02115
Site Public Contact
617-724-5200
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
Detailed Description
PRIMARY OBJECTIVES: To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth). OUTLINE: 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.