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Acute Cardiovascular Adverse Events Occuring in Children Treated by Anticancer Drugs for Malignancies

Sponsor
University Hospital, Caen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05602103
Collaborator
(none)
10,000
Enrollment
50
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Little is known about acute cardiovascular adverse events 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 acute cardiovascular adverse events associated with anticancer drugs.

Condition or Disease Intervention/Treatment Phase
  • Drug: use of anticancer drugs in monotherapy or in combination therapy

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Description of Acute Cardiovascular Adverse Events Occuring in Children Treated by Anticancer Drugs for Malignancies Using the World Health Organization (WHO) Database VigiBase
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2027

Outcome Measures

Primary Outcome Measures

  1. Acute cardiovascular adverse events associated with anticancer drugs [from inception to the octobre 31, 2022]

    identification and description of cases of acute cardiovascular adverse events associated with anticancer drugs in the World Health Organization (WHO) database of individual safety case reports (vigibase)

Secondary Outcome Measures

  1. Association between acute cardiovascular adverse events and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase) [from inception to the octobre 31, 2022]

    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)

  2. Description of the malignancies for which the incriminated drugs have been prescribed [from inception to the octobre 31, 2022]

    Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

  • related to children

  • and reported, or not, acute cardiovascular adverse events

Exclusion Criteria:

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

  • cases related to long-term and delayed cardiovascular adverse events

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

  • Principal Investigator: Joachim Alexandre, MD, PhD, Caen Normandy University Hospital, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05602103
Other Study ID Numbers:
  • Pharmaco_112022
First Posted:
Nov 1, 2022
Last Update Posted:
Nov 1, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Neoplasms
Cardiovascular Diseases

Study Results

No Results Posted as of Nov 1, 2022