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NCT01805778 · ClinicalTrials.gov registry record
Preventing Cardiac Sequelae in Pediatric Cancer Survivors
A clinical trial of Anthracycline-induced Cardiotoxicity, sponsored by The Hospital for Sick Children.
- Completed
- Registry status
- 1,128
- Enrollment target
- 6
- Study locations
NCT01805778: Completed study of Anthracycline-induced Cardiotoxicity, sponsored by The Hospital for Sick Children.
NCT01805778 is a study of Anthracycline-induced Cardiotoxicity that has completed, run by The Hospital for Sick Children. The registered enrollment target is 1,128 participants. The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805778, a study of Anthracycline-induced Cardiotoxicity, has completed, sponsored by The Hospital for Sick Children.
- COMPLETED
- Registry status
- 1,128 participants
- Enrollment target
- 6
- Study locations
Study 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 treatment-related heart disease are usually ineffective at preventing its progression to death or heart transplant. Our team will work in several research cores to test new imaging and biomarker methods that will lead to earlier detection of heart disease before clinical symptoms develop or it become apparent on standard imaging tests. We will evaluate the importance of genetic differences between individuals in determining who is at greatest risk of developing heart disease as a result of exposure to cardiotoxic agents. We will combine this genetic information with the novel imaging and biomarker methods to predict which children are at particular risk. These vulnerable children can then be targeted by modifying their cancer therapy to reduce their exposure to cardiac toxins, or introducing medications that protect the heart from chemotherapy damage. This team brings together the expertise of clinicians and scientists in pediatric oncology, pediatric and adult cardiology, radiation oncology, genetics, and biostatistics. This is a cross-Canada initiative that will leverage the latest knowledge about cardiac toxicity and create a resource for ongoing research into this important cause of morbidity and mortality in childhood cancer survivors.
Primary Outcome
The presence of one or more of the following: 1. 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 2. Reduced left ventricular ejection fraction (LV EF) (\<55%); or 3. Symptomatic heart failure graded using New York Heart Association (NYHA) classification (or Ross heart failure class at least 2 in infants less than 2
Conditions Studied
Study Locations (6)
Ontario
- McMaster Children's Hospital - Hamilton
- London Health Sciences Centre - London
- Children's Hospital of Eastern Ontario - Ottawa
- SickKids - Toronto
- Princess Margaret Hospital - Toronto
California
- Children's Hospital of Orange County - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,128 participants |
| Start Date | 2012-12 |
| Est. Completion | 2018-09 |
What the finished NCT01805778 record still lists
NCT01805778 is an observational study that tracks outcomes without assigning an intervention. Its 1,128 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Anthracycline-induced Cardiotoxicity appearing as the primary indexed condition, and to 0 interventions.
NCT01805778 lists 6 locations in 2 states (Ontario, California).
Frequently Asked Questions
What is clinical trial NCT01805778 about?
NCT01805778 is a clinical study titled "Preventing Cardiac Sequelae in Pediatric Cancer Survivors". 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 treatment-related heart disease are usually ineffective at preventing its progression to death or heart tran...
What is the current status of trial NCT01805778?
This trial is currently completed. The enrollment target is 1,128 participants. The study started on 2012-12. Estimated completion is 2018-09.
What conditions does trial NCT01805778 study?
This clinical trial studies the following conditions: Anthracycline-induced Cardiotoxicity.
Who is sponsoring clinical trial NCT01805778?
This trial is sponsored by The Hospital for Sick Children, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01805778 being conducted?
This trial has 6 study locations across California, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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