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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05602103

Enrollment

10000

Registered

2022-11-01

Start date

2024-11-05

Completion date

2025-01-06

Last updated

2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Children, Only, Malignancies

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.

Interventions

DRUGuse of anticancer drugs in monotherapy or in combination therapy

Cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs will be identify and describe

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
cancer therapy-related cardiac dysfunction associated with anticancer drugs	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

Measure	Time frame	Description
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	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)
Description of the malignancies for which the incriminated drugs have been prescribed	from inception to the April 31, 2024	Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)

Contacts

Primary ContactJoachim Alexandre, MD, PhD

alexandre-j@chu-caen.fr+330231064770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026