Clinical trial · Observational
Immuno-Oncology Database and Bioregistry
Lineberger Comprehensive Cancer Center (LCCC) 1937: Immuno-Oncology Database and Bioregistry: Identifying Mechanisms of Autoimmune Diseases in the Era of Cancer Immunotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Diseases | — | UNRESOLVED | — |
| Immune System Diseases | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Questionnaires/Surveys | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ICI treatment
- description
- Adult cancer patients starting ICI monotherapy or combination therapy at UNC Chapel Hill per clinical standard of care and willing to allow specimens from surplus tissue to be banked for research purposes (in the case of resections) AND willing to have additional specimens taken for research purposes (in the case of biopsies). Patients will be followed for samples and clinical data from medical records from before starting ICI therapy until 2 years after the end of ICI treatment.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Medical Chart Review
- Other: Questionnaires/Surveys
Primary outcomes (1)
- measure
- Number of Participants With Immune Checkpoint Inhibitor Treatment-Related Adverse Events as Assessed by CTCAE v5.0
- timeFrame
- Up to 2 years after end of ICI treatment
- description
- Clinical database with a linked specimen biorepository from this cohort - including management of irAEs and underlying cancer, irAE and cancer outcomes, surveys (PROs) and specimen collection from various time points during and after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available