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Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy

This study is currently recruiting participants.
Verified February 2017 by Olga Salazar, Connecticut Children's Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671696
First Posted: August 23, 2012
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Olga Salazar, Connecticut Children's Medical Center
  Purpose
The main hypothesis being tested is that imaging and serologic biomarkers of apoptosis and progressive extracellular matrix remodeling will precede echocardiographic indices of systolic and diastolic function among childhood cancer survivors treated with anthracyclines thus allowing evaluation of new therapies to prevent and manage heart failure in these patients.

Condition Intervention
Cardiovascular Disease Other: Cardiac MRI

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy: A Cardiac Magnetic Resonance and Biomarker Imaging and Serological Biomarker Study

Further study details as provided by Olga Salazar, Connecticut Children's Medical Center:

Primary Outcome Measures:
  • To see if a CMRI is better at detecting occult asymptomatic cardiotoxicity [ Time Frame: 1 year ]
    Changes in T1 mapping-derived relaxation time and left ventricular myocardial peak circumference strain are present in asymptomatic post-chemotherapy pediatric patients who have normal standard CMRI parameters. Circumferential strain analysis and measurement of the T1 myocardial relaxation time by CMRI may accurately identify occult cardiovascular dysfunction in patients exposed to high dose anthracyclines.


Secondary Outcome Measures:
  • Have a low shortening fraction is an indicator of cardiotoxicity [ Time Frame: 1 year ]
    Shortening Fraction < 29% during chemotherapy or at follow-up, even if transient, serves as an early marker for cardiotoxicity (Lower EF, LV Mass, and increased ESWS).


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cardiac MRI
    Cardiac MRI
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Survivors of childhood cancer who were treated with anthracyclines and are greater than 2 years from their last cycle of chemotherapy
Criteria

Inclusion Criteria:

  • Childhood cancer survivors from the late effect clinic who had been in continuous, complete remission and off chemotherapy for a minimum of 2 years.
  • Age > 9 years of age

Exclusion Criteria:

  • Contraindications to CMRI
  • Relapse of their cancer
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01671696


Locations
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Nancy Cronin    860-837-5881      
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: Olga Salazar, MS Connecticut Childrens Med Ctr
  More Information

Responsible Party: Olga Salazar, Assistant Clinical Professor, Pediatric Cardiology, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT01671696     History of Changes
Other Study ID Numbers: 10-096 CCMC
First Submitted: August 21, 2012
First Posted: August 23, 2012
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: pending PI review.

Additional relevant MeSH terms:
Cardiovascular Diseases
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries