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

Recruiting

• Conditions: Malignancy

• Registration Number: NCT04242095
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Study Start: 2020-03-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of a national biorepository including biospecimen and clinical data collections for future use	Up to 1 year	The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.

Trial Locations

Locations (617)

CommonSpirit Cancer Center Mercy; 🇺🇸 Durango, Colorado, United States

Rush-Copley Medical Center; 🇺🇸 Aurora, Illinois, United States

UI Healthcare Mission Cancer and Blood - Fort Dodge; 🇺🇸 Fort Dodge, Iowa, United States

Mercy Oncology and Hematology - Clayton-Clarkson; 🇺🇸 Ballwin, Missouri, United States

Mercy Infusion Center - Chippewa; 🇺🇸 St Louis, Missouri, United States

Providence Hood River Memorial Hospital; 🇺🇸 Hood River, Oregon, United States

VCU Massey Comprehensive Cancer Center; 🇺🇸 Richmond, Virginia, United States

Anchorage Associates in Radiation Medicine; 🇺🇸 Anchorage, Alaska, United States

Anchorage Radiation Therapy Center; 🇺🇸 Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC; 🇺🇸 Anchorage, Alaska, United States

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