Status:
COMPLETED
Preventing Cardiac Sequelae in Pediatric Cancer Survivors
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Ontario Institute for Cancer Research
Conditions:
Anthracycline-induced Cardiotoxicity
Eligibility:
All Genders
Up to 18 years
Brief Summary
Cancer therapy can place childhood cancer survivors at increased risk for heart disease which can lead to significant illness or early death. Interventions that occur late in the evolution of treatmen...
Detailed Description
This is a multi-centre observational cohort study that will be conducted at The Hospital for Sick Children (Toronto), Princess Margaret Hospital (Toronto), McMaster Children's Hospital (Hamilton), Lon...
Eligibility Criteria
Inclusion
- ACUTE COHORT:
- Aged \<18 years at time of cancer diagnosis
- Diagnosed with a new malignancy (patients with a history of a prior malignancy wlil be eligible if they have not received any anthracycline chemotherapy or chest radiation)
- Cancer treatment plan will require therapy with at least one dose of any anthracycline
- Planned to have all pre-anthracycline echocardiograms (ECHO) at the recruiting site
- Normal cardiac functioning prior to initiation of anthracycline therapy (LV EF \> 55%)
- Patients who are uncooperative during the ECHO without sedation or anesthesia will be included in the study. However, these patients will only undergo clinically indicated echocardiograms, with no echocardiograms added for purely research purposes
- Provision of signed informed consent by the patient and/or patient's legal guardian
Exclusion
- Patients who were previously treated with anthracycline chemotherapy or radiation to the chest.
- Significant congenital heart defects, including patients with any other congenital cardiac abnormality, except those with a patent foramen ovale or a small ASD. Patients with familial cardiomyopathies (hypertrophic, dilated and restrictive) will be excluded.
- SURVIVOR COHORT:
- Inclusion Criteria:
- Aged \< 18 years at time of cancer diagnosis
- Previously diagnosed with cancer and currently in remission
- Patients whose prior treatment plan included therapy with at least one dose of any anthracycline
- Patients who completed their final dose of anthracycline at least 3 years ago
- Routinely followed at the recruiting site approximately ever 12 months
- Exclusion Criteria
- Prior allogeneic stem cell transplant
- Significant congenital heart defects, including patients with any other congenital cardiac abnormality, except those with a patent foramen ovale or a small ASD. Patients with familial cardiomyopathies (hypertrophic, dilated and restrictive) will be excluded.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
1128 Patients enrolled
Trial Details
Trial ID
NCT01805778
Start Date
December 1 2012
End Date
September 1 2018
Last Update
July 8 2019
Active Locations (6)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
McMaster Children's Hospital
Hamilton, Ontario, Canada
3
London Health Sciences Centre
London, Ontario, Canada
4
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada