NCT04242095

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Malignancy

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of tissue, blood, and stool samples
OTHER	Medical Chart Review	Review of medical records

Timeline

• Start date: 2020-03-12
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2020-01-27
• Last updated: 2026-04-07

Locations

626 sites across 1 country: United States