AzTrials
AzTrials

MalignanciesNCT05602103

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

An observational study of Malignancies and Cardiovascular Diseases, run by University Hospital, Caen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 0 to 18 years
What is being tested?
use of anticancer drugs in monotherapy or in combination therapy
How many people
10,000 participants
Where
No sites listed yet
Study dates
5 Nov 2024to 6 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: 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

Who may be able to join

  • 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

Who cannot join

  • cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients

Trial locations and contacts

No sites are listed yet.

Joachim Alexandre, MD, PhD contact

+330231064770

alexandre-j@chu-caen.fr

About this study

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

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.

Being tested
use of anticancer drugs in monotherapy or in combination therapy
Medical subject headings
Neoplasms, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • use of anticancer drugs in monotherapy or in combination therapyDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: from inception to the April 31, 2024

Secondary outcomes (2)

  1. 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)

    Measured: from inception to the April 31, 2024

  2. 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)

    Measured: from inception to the April 31, 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2022
  2. Study start5 Nov 2024 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion6 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05602103
Sponsor's protocol ID
Pharmaco_112022
Status last verified
Apr 2024
First submitted
27 Oct 2022
Last updated
29 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Labombarda F, Rouger J, Legallois D, Dolladille C, Alexandre J, Chretien B. Identification of Anticancer Drugs Associated With Cancer Therapy-Related Cardiac Dysfunction in Pediatrics-Analysis of the WHO Pharmacovigilance Database. Pediatr Blood Cancer. 2025 Jul;72(7):e31727. doi: 10.1002/pbc.31727. Epub 2025 Apr 20.

    PubMed 40254815

Questions about this trial

What is this clinical trial studying?

An observational study of Malignancies and Cardiovascular Diseases, run by University Hospital, Caen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joachim Alexandre, MD, PhD (+330231064770, alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cancer therapy-related cardiac dysfunction associated with anticancer drugs (time frame: from inception to the April 31, 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in