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Immuno-Oncology Database and Bioregistry

NCT04656873 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2025-09-04

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of cheek swab, blood, urine, stool, and tissue samples for research

OTHER

Medical Chart Review

Periodic review of medical records for clinical parameters (labs, ICI dosing and frequency, occurrence, timing and type of irAE, irAE management, etc.) along with relevant demographic information (age, sex/gender, race/ethnicity, insurance type, etc.).

OTHER

Questionnaires/Surveys

Periodic self-report questionnaires/surveys for symptom tracking, quality of life, perinatal outcomes, etc.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2026-06-04
Completion
2026-06-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04656873 on ClinicalTrials.gov