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
1 other identifier
observational
10,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
November 1, 2022
CompletedStudy Start
First participant enrolled
November 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2025
CompletedMay 29, 2024
April 1, 2024
2 months
October 27, 2022
May 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Interventions
Cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs will be identify and describe
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Joachim Alexandre, MD, PhD
Caen Normandy University Hospital, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2022
First Posted
November 1, 2022
Study Start
November 5, 2024
Primary Completion
January 1, 2025
Study Completion
January 6, 2025
Last Updated
May 29, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share