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

a study on Neoplasms Immunotherapy

Summary

Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Malignancy, Neoplasms, Biospecimen Collection, Medical Chart Review

Eligibility

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

Locations

  • Zuckerberg San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center accepting new patients
    Burbank California 91505 United States
  • Bay Area Breast Surgeons Inc in progress, not accepting new patients
    Emeryville California 94608 United States
  • Epic Care Partners in Cancer Care in progress, not accepting new patients
    Emeryville California 94608 United States
  • Woodland Memorial Hospital accepting new patients
    Woodland California 95695 United States
  • Bay Area Tumor Institute in progress, not accepting new patients
    Oakland California 94609 United States
  • Mercy Cancer Center - Sacramento accepting new patients
    Sacramento California 95816 United States
  • Mercy Cancer Center - Elk Grove accepting new patients
    Elk Grove California 95758 United States
  • Contra Costa Regional Medical Center accepting new patients
    Martinez California 94553-3156 United States
  • Epic Care Cyberknife Center in progress, not accepting new patients
    Walnut Creek California 94597 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT04242095
Study Type
Observational
Participants
Expecting 240 study participants
Last Updated