Cancer Therapy-related Cardiac Dysfunction Occuring in Children Treated by Anticancer Drugs for Malignancies

May 28, 2024 updated by: University Hospital, Caen

Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction Reporting in Pediatrics - Analysis of the WHO Pharmacovigilance Database

Little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to children and reported, or not, cancer therapy-related cardiac dysfunction

Description

Inclusion Criteria:

  • cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
  • related to children
  • and reported, or not, cancer therapy-related cardiac dysfunction

Exclusion Criteria:

  • cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cancer therapy-related cardiac dysfunction associated with anticancer drugs
Time Frame: from inception to the April 31, 2024
identification and description of cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs in the World Health Organization (WHO) database of individual safety case reports (vigibase)
from inception to the April 31, 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between cancer therapy-related cardiac dysfunction and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase)
Time Frame: from inception to the April 31, 2024
Disproportionnality analyses in Vigibase (IC025 and/or ROR) perfomed on cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
from inception to the April 31, 2024
Description of the malignancies for which the incriminated drugs have been prescribed
Time Frame: from inception to the April 31, 2024
Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
from inception to the April 31, 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Joachim Alexandre, MD, PhD, Caen Normandy University Hospital, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 5, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 6, 2025

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharmaco_112022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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