Preventing Cardiac Sequelae in Pediatric Cancer Survivors (PCS2)
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|ClinicalTrials.gov Identifier: NCT01805778|
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : July 8, 2019
|Condition or disease|
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), London Health Sciences Centre (London), The Children's Hospital of Eastern Ontario (Ottawa) and The Children's Hospital of Orange County (Orange County, California).
The study will address the current limitations in prediction and early diagnosis of anthracycline-induced heart disease. This will be accomplished by the following 3 collaborative cores:
Core 1 (Genomics) will focus on determining which children are most susceptible to treatment-related cardiac toxicity by assessing genes in pathways related to anthracycline absorption, distribution, metabolism, and excretion, as well identifying genes in pathways known to be important in the cardiac response to injury.
Core 2 (Biomarkers) will explore whether existing and novel biomarkers allow for more accurate diagnosis of acute and late treatment-related cardiac toxicity. The core will use a human stem cell platform for discovery of novel biomarkers of anthracycline cardiac damage that will be evaluated in our clinical cohort.
Core 3 (Cardiac imaging) will focus on the evaluation of new echocardiographic and CMR techniques aimed at early identification of cardiac damage after anthracycline exposure.
It will investigate whether changes in cardiac function immediately after anthracycline administration predict which patients will develop progressive cardiac disease over time, and it will explore disease progression through the longitudinal evaluation of innovative echocardiographic parameters of remodeling and dysfunction in CCS exposed to anthracyclines.
|Study Type :||Observational|
|Actual Enrollment :||1128 participants|
|Official Title:||Novel Approaches to the Prediction, Diagnosis and Treatment of Cardiac Late Effects in Survivors of Childhood Cancer: A Multi-centre Observational Study|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Patients newly diagnosed with cancer who will be receiving anthracycline chemotherapy
Survivors of childhood cancer who are at least 3 years or more from their last dose of anthracycline therapy.
- Cardiac Remodeling [ Time Frame: one year after last dose of anthracycline therapy in Acute Cohort; anytime during 2 year follow up in Survivor Cohort ]
The presence of one or more of the following:
- Cardiac Remodeling defined as Left Ventricular Posterior Wall Thickness (LVPWT) or Thickness to Dimension Ratio (TDR) z-score <-2.0 or a reduction in LVPWT or TDR z-score by at least 1 standard deviation compared to baseline; or
- Reduced left ventricular ejection fraction (LV EF) (<55%); or
- Symptomatic heart failure graded using New York Heart Association (NYHA) classification (or Ross heart failure class at least 2 in infants less than 2 years old)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805778
|United States, California|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada|
|London Health Sciences Centre|
|London, Ontario, Canada|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada|
|Toronto, Ontario, Canada, M5G1XE|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5T2M9|
|Principal Investigator:||Paul C Nathan, M.D.||The Hospital for Sick Children|
|Principal Investigator:||Mark Greenberg, M.D.||The Hospital for Sick Children|
|Principal Investigator:||Seema Mital, M.D.||The Hospital for Sick Children|
|Principal Investigator:||Luc Mertens, M.D.||The Hospital for Sick Children|
|Principal Investigator:||Paul Kantor, M.D.||University of Alberta, Stollery Children's Hospital|
|Principal Investigator:||Peter Liu, M.D.||Ottawa Heart Institute|