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

  • STATUS
    Recruiting
  • participants needed
    240
  • sponsor
    Alliance for Clinical Trials in Oncology
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Updated on 19 February 2024
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biospecimen collection

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.

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 3-5) 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.

Details
Condition Cancer
Age 100years or below
Treatment Biospecimen Collection, Medical Chart Review
Clinical Study IdentifierNCT04242095
SponsorAlliance for Clinical Trials in Oncology
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Must have received one or more IO therapeutics
Must have experienced one or more of the following
One or more serious (grade 3-5) AEs that are likely immune-related
Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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