Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects

a study on Hematopoietic and Lymphoid Cell Neoplasm Solid Neoplasm Immunotherapy Hematologic Neoplasms

Summary

Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Terence W. Friedlander (ucsf)
Headshot of Terence W. Friedlander
Terence W. Friedlander

Description

Summary

This study 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 96 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for 1 year.

Keywords

Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder, Malignant Solid Neoplasm, Hematologic Neoplasms, Immune System Diseases, Biospecimen Collection, Medical Chart Review

Eligibility

  • PRE-REGISTRATION ELIGIBILITY CRITERIA: Planning to receive a regimen containing one or more IO therapeutics
  • PRE-REGISTRATION ELIGIBILITY CRITERIA: Has not previously been treated with CTLA-4, PD-1 or PD-L1 inhibitors
  • PRE-REGISTRATION ELIGIBILITY CRITERIA: Willing and able to provide baseline blood and stool samples
  • REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics
    • Must have received one or more IO therapeutics
    • In addition to one or more IO therapeutics, patients may also have received other therapeutics such as chemotherapy, hormonal or targeted therapy, as long as these are reported
  • REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following:

    • One or more serious (grade 3-54) AEs that are likely immune-related. AEs included in Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 that may be immune-related

      ** Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded

    • One or more grade 2 dermatologic, endocrine (except diabetes/hyperglycemia) or rheumatologic AEs that are likely immune-related. AEs included in CTCAE v. 5.0 that may be 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
  • REGISTRATION ELIGIBILITY CRITERIA: Has not previously been registered to this study
    • The same patient cannot be enrolled more than once to this study due to development of subsequent irAEs

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 in progress, not 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 in progress, not accepting new patients
    Sacramento California 95816 United States
  • Mercy Cancer Center - Elk Grove in progress, not accepting new patients
    Elk Grove California 95758 United States
  • Contra Costa Regional Medical Center in progress, not 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

Lead Scientist at University of California Health

  • Terence W. Friedlander (ucsf)
    I am a clinical and translational medical oncologist with a focused on urologic cancers, specifically cancers of the bladder, prostate, and kidney. I am also the Chief of the ZSFG Division of Hematology and Oncology. My research is focused on understanding the basic biology of urologic and other malignancies and in developing novel therapeutic ways to treat disease.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT04242095
Study Type
Observational
Participants
Expecting 2240 study participants
Last Updated
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