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Clinical Trials/NCT05602103
NCT05602103Not yet recruitingNot Applicable

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

University Hospital, Caen0 sites10,000 target enrollmentStarted: November 5, 2024Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
10,000
Primary Endpoint
cancer therapy-related cardiac dysfunction associated with anticancer drugs
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
0 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Association between cancer therapy-related cardiac dysfunction and anticancer drug exposure 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(from inception to the April 31, 2024)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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