Database for understanding immune-related side effects of cancer immunotherapy
Lineberger Comprehensive Cancer Center (LCCC) 1937: Immuno-Oncology Database and Bioregistry: Identifying Mechanisms of Autoimmune Diseases in the Era of Cancer Immunotherapy.
This study is trying to gather information from cancer patients on immune-related side effects from immunotherapy to better understand who might be at risk and how to manage these effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | Immunotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT04656873 on ClinicalTrials.gov |
What this trial studies
This project aims to create a collaborative infrastructure for researchers to study immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) used in cancer treatment. By collecting data and biological samples from patients starting or restarting ICI therapy, the study seeks to identify who is at risk for irAEs and how to manage them effectively. The research will involve medical chart reviews, biospecimen collection, and patient questionnaires to gather comprehensive information on the effects of ICIs. The ultimate goal is to enhance the understanding of irAEs and improve patient outcomes during immunotherapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with cancer and are starting or restarting ICI therapy.
Not a fit: Patients who have received prior ICI treatment within the last two years or have untreated communicable diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better management strategies for patients experiencing immune-related side effects from cancer immunotherapy.
How similar studies have performed: While the study focuses on a specific aspect of immunotherapy, similar research has shown promise in understanding and managing immune-related adverse events in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Rumey C Ishizawar, MD, PhD — UNC Chapel Hill
- Study coordinator: Shivani R Surati, MS
- Email: shivani_surati@med.unc.edu
- Phone: 919-966-7597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.