Immuno-Oncology Database and Bioregistry

Description

Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many different types of cancers. ICIs fight cancer by driving the immune system into an "activated state" that makes it harder for tumor cells to hide and easier for the immune system to destroy them. In doing this, oncologists risk "over activation" where immune cells can cause side effects that could affect any part of the body. These are known as immune related adverse events (irAEs). While irAEs are a known risk of ICIs, scientists and doctors do not understand how they develop, who is more likely to get them, and what is the best way to manage them while still getting the anti-tumor effects from ICIs. The aim of this project is to build an infrastructure for researchers to collaborate in clinical, translational, and basic science research focused on understanding and managing immune related adverse events (irAEs). The investigators will collect research data and samples from patients who receive ICI treatment, including when patients might experience immunotherapy side effects, to store for use in future research studies.

Conditions

Malignancy, Immune System Diseases, Autoimmune Diseases

Study Overview

Study Details

Study overview

Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many different types of cancers. ICIs fight cancer by driving the immune system into an "activated state" that makes it harder for tumor cells to hide and easier for the immune system to destroy them. In doing this, oncologists risk "over activation" where immune cells can cause side effects that could affect any part of the body. These are known as immune related adverse events (irAEs). While irAEs are a known risk of ICIs, scientists and doctors do not understand how they develop, who is more likely to get them, and what is the best way to manage them while still getting the anti-tumor effects from ICIs. The aim of this project is to build an infrastructure for researchers to collaborate in clinical, translational, and basic science research focused on understanding and managing immune related adverse events (irAEs). The investigators will collect research data and samples from patients who receive ICI treatment, including when patients might experience immunotherapy side effects, to store for use in future research studies.

Lineberger Comprehensive Cancer Center (LCCC) 1937: Immuno-Oncology Database and Bioregistry: Identifying Mechanisms of Autoimmune Diseases in the Era of Cancer Immunotherapy.

Immuno-Oncology Database and Bioregistry

Condition
Malignancy
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years of age at time of enrollment
  • * Diagnosis of cancer
  • * Starting initial ICI therapy or re-starting ICI treatment after a 2-year gap (including off-label use) at UNC-CH using any currently FDA approved ICI's.
  • * Prior ICI treatment within the last 2 years, including FDA approved ICIs and those under investigation (clinical trials).
  • * Known and untreated BSL-2+ communicable diseases (active/untreated latent TB, HIV, etc.) or other active infections.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UNC Lineberger Comprehensive Cancer Center,

Rumey C Ishizawar, MD, PhD, PRINCIPAL_INVESTIGATOR, UNC Chapel Hill

Study Record Dates

2031-04