Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

Conditions
-----------------
Malignancy

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection
* Other: Medical Chart Review


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (biospecimen collection, medical record review)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of tissue, blood, and stool samples<br>Other: Medical Chart Review<br>* Review of medical records<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a national biorepository including biospecimen and clinical data collections for future use | The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study. | Up to 1 year |