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

NCT ID: NCT05602103

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-01-06

Brief Summary

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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

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Conditions

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Malignancies Cardiovascular Diseases Children, Only

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joachim Alexandre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Caen Normandy University Hospital, France

Central Contacts

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Joachim Alexandre, MD, PhD

Role: CONTACT

+330231064770

Other Identifiers

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Pharmaco_112022

Identifier Type: -

Identifier Source: org_study_id

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