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

Not yet recruiting

• Conditions: Malignancies; Children, Only; Cardiovascular Diseases

• Registration Number: NCT05602103
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Study Start: 2024-11-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)