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

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.

Study summary:

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.

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 is Available At:

Original ID:

A151804

NCT ID:

NCT04242095

Secondary ID:

NCI-2019-07113

Study Acronym:

Brief Title:

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

Official Title:

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

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT04242095

Overall Status:

Recruiting

Study Phase:

N/A

Genders:

N/A

Minimum Age:

N/A

Maximum Age:

N/A

Study Source:

Alliance for Clinical Trials in Oncology

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Observational

Study Design:

Number of Arms:

0

Number of Groups:

1

Total Enrollment:

240

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: February 08, 2023

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