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NCT04898751 · ClinicalTrials.gov registry record

Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors

A clinical trial of Cutaneous Toxicity From ICI Therapy, sponsored by Johns Hopkins University.

Completed
Registry status
2,214
Enrollment target
1
Study location

NCT04898751: Completed study of Cutaneous Toxicity From ICI Therapy, sponsored by Johns Hopkins University.

NCT04898751 is a study of Cutaneous Toxicity From ICI Therapy that has completed, run by Johns Hopkins University. The registered enrollment target is 2,214 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04898751, a study of Cutaneous Toxicity From ICI Therapy, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
2,214 participants
Enrollment target
1
Study location

Study Summary

Immune checkpoint inhibitors (ICIs) are associated with a wide variety of cutaneous immune-related adverse events (cirAEs). These cirAEs are reported to be the most common immune-related adverse events (irAEs) and the first to appear. This study examines the appearance of cirAEs within the World Health Organization (WHO) pharmacovigilance database, VigiBase.

Primary Outcome

Number of reported adverse events associated with ICIs within the Systems Organ Class (SOC) "Skin and subcutaneous disorders" with one of the 7 FDA-approved ICIs Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), or Cemiplimab (L01XC33), alone or in any combination with each other.

Interventions

  • DRUG Immune checkpoint inhibitor (ICI)

Study Locations (1)

Maryland

  • Sidney Kimmel Comprehensive Care Center - Baltimore

Trial Details

FieldValue
Enrollment Target 2,214 participants
Start Date 2008-01-01
Est. Completion 2020-08-31
Johns Hopkins University

1,448 total trials

What the finished NCT04898751 record still lists

NCT04898751 is an observational study that tracks outcomes without assigning an intervention. Its 2,214 participants enrollment target places it among the larger protocols in the corpus.

The record links to 1 condition, with Cutaneous Toxicity From ICI Therapy appearing as the primary indexed condition, and to 1 intervention - of which Immune checkpoint inhibitor (ICI) is the first listed.

NCT04898751 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT04898751 about?

NCT04898751 is a clinical study titled "Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors". Immune checkpoint inhibitors (ICIs) are associated with a wide variety of cutaneous immune-related adverse events (cirAEs). These cirAEs are reported to be the most common immune-related adverse events (irAEs) and the first to appear. This study examines the appearance of cirAEs within the World Hea...

What is the current status of trial NCT04898751?

This trial is currently completed. The enrollment target is 2,214 participants. The study started on 2008-01-01. Estimated completion is 2020-08-31.

What conditions does trial NCT04898751 study?

This clinical trial studies the following conditions: Cutaneous Toxicity From ICI Therapy.

What interventions are being tested in trial NCT04898751?

The interventions under investigation include: Immune checkpoint inhibitor (ICI) (DRUG).

Who is sponsoring clinical trial NCT04898751?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04898751 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04898751, the US trial registry maintained by the National Library of Medicine. NCT04898751 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.