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NCT05602103 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05602103
Other study ID # Pharmaco_112022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 5, 2024
Est. completion date January 6, 2025

Study information
Verified date April 2024
Source University Hospital, Caen
Contact Joachim Alexandre, MD, PhD
Phone +330231064770
Email alexandre-j@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10000
Est. completion date January 6, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• use 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Outcome
Type Measure Description Time frame Safety issue
Primary cancer therapy-related cardiac dysfunction associated with anticancer drugs 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 Association between cancer therapy-related cardiac dysfunction and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase) 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
Secondary Description of the malignancies for which the incriminated drugs have been prescribed Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) from inception to the April 31, 2024
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