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

NCT04242095

RecruitingN/A

Sponsor: Alliance for Clinical Trials in Oncology

Conditions: Malignancy

Interventions: Biospecimen Collection, Medical Chart Review

Countries: United States

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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 (625)
  • Anchorage, Alaska, United States
  • Anchorage, Alaska, United States
  • Anchorage, Alaska, United States
  • Anchorage, Alaska, United States
  • Anchorage, Alaska, United States
  • Anchorage, Alaska, United States
  • Anchorage, Alaska, United States
  • Anchorage, Alaska, United States
  • Fairbanks, Alaska, United States
  • Kingman, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Fort Smith, Arkansas, United States
  • Hot Springs, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Arroyo Grande, California, United States
  • Arroyo Grande, California, United States
  • Burbank, California, United States
  • Carmichael, California, United States
  • Carmichael, California, United States
  • Dublin, California, United States
  • Elk Grove, California, United States
  • Emeryville, California, United States
  • Emeryville, California, United States
  • Fremont, California, United States
  • Loma Linda, California, United States
  • Martinez, California, United States
  • Merced, California, United States
  • Oakland, California, United States
  • Rocklin, California, United States
  • + 595 more on CT.gov