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Novel Approaches to the Prediction, Diagnosis and Treatment of Cardiac Late Effects in Survivors of Childhood Cancer: A Multi-centre Observational Study


N/A
N/A
18 Years
Open (Enrolling)
Both
Anthracycline-induced Cardiotoxicity

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Trial Information

Novel Approaches to the Prediction, Diagnosis and Treatment of Cardiac Late Effects in Survivors of Childhood Cancer: A Multi-centre Observational Study


ACUTE COHORT:

Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Cardiac Remodeling

Outcome Description:

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)

Outcome Time Frame:

one year after last dose of anthracycline therapy in Acute Cohort; anytime during 2 year follow up in Survivor Cohort

Safety Issue:

No

Principal Investigator

Paul C Nathan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital for Sick Children

Authority:

Canada: Research Ethics Board

Study ID:

1000032746

NCT ID:

NCT01805778

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Anthracycline-induced Cardiotoxicity

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