ACTIVE_NOT_RECRUITING

Immuno-Oncology Database and Bioregistry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-05-20
Study Completion:2026-06-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04656873

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age at time of enrollment
  2. * Diagnosis of cancer
  3. * 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.
  1. * Prior ICI treatment within the last 2 years, including FDA approved ICIs and those under investigation (clinical trials).
  2. * Known and untreated BSL-2+ communicable diseases (active/untreated latent TB, HIV, etc.) or other active infections.

Contacts and Locations

Principal Investigator

Rumey C Ishizawar, MD, PhD
PRINCIPAL_INVESTIGATOR
UNC Chapel Hill

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-20
Study Completion Date2026-06-04

Study Record Updates

Study Start Date2021-05-20
Study Completion Date2026-06-04

Terms related to this study

Keywords Provided by Researchers

  • cancer
  • immunotherapy
  • immune checkpoint inhibitors
  • immune related adverse events
  • autoimmune diseases

Additional Relevant MeSH Terms

  • Malignancy
  • Immune System Diseases
  • Autoimmune Diseases