Immuno-Oncology Database and Bioregistry

NCT04656873 | Active Not Recruiting

• 2 other identifiers: LCCC193718-0560
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Malignancy; Immune System Diseases; Autoimmune Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Immune Checkpoint Inhibitor Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  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.

  Up to 2 years after end of ICI treatment

Study Arms (1)

ICI treatment

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.

Procedure: Biospecimen Collection; Other: Medical Chart Review; Other: Questionnaires/Surveys

Interventions

Biospecimen Collection PROCEDURE

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

ICI treatment

Medical Chart Review OTHER

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.).

ICI treatment

Questionnaires/Surveys OTHER

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

ICI treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cancer patients starting ICI monotherapy or combination therapy at University of North Carolina at Chapel Hill (UNC-CH).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• University of North Carolina, Chapel Hill: collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

cheek swab, blood, urine, feces, medical waste tissue/fluids, research biopsies.

MeSH Terms

Conditions

Neoplasms; Immune System Diseases; Autoimmune Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rumey C Ishizawar, MD, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 7, 2020
• Study Start: May 20, 2021
• Primary Completion (Estimated): June 4, 2026
• Study Completion (Estimated): June 4, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon request.
• Access Criteria: Any pertinent regulatory agreements and approvals are in place.

Locations

US (1)