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NCT04656873 · ClinicalTrials.gov registry record
Immuno-Oncology Database and Bioregistry
A clinical trial of Autoimmune Diseases and Immune System Diseases, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- 32
- Enrollment target
- 1
- Study location
NCT04656873: Active study of Autoimmune Diseases and Immune System Diseases, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT04656873 is a study of Autoimmune Diseases and Immune System Diseases that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 32 participants, below the 977-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04656873, a study of Autoimmune Diseases and Immune System Diseases, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- 32 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Medical Chart Review
- OTHER Questionnaires/Surveys
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2026-06-04 |
What the registry record for NCT04656873 still lists
NCT04656873 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 977-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Autoimmune Diseases appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT04656873 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04656873 about?
NCT04656873 is a clinical study titled "Immuno-Oncology Database and Bioregistry". 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 t...
What is the current status of trial NCT04656873?
This trial is currently active not recruiting. The enrollment target is 32 participants. The study started on 2021-05-20. Estimated completion is 2026-06-04.
What conditions does trial NCT04656873 study?
This clinical trial studies the following conditions: Autoimmune Diseases, Immune System Diseases, Malignancy.
What interventions are being tested in trial NCT04656873?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Medical Chart Review (OTHER), Questionnaires/Surveys (OTHER).
Who is sponsoring clinical trial NCT04656873?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04656873 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autoimmune Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04656873's enrollment target sits among peer trials
32 19th of 25 higher than 7 of 25 other Autoimmune Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autoimmune Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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