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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Connecticut Children's Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Olga Salazar, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT01671696
First received: August 21, 2012
Last updated: NA
Last verified: May 2011
History: No changes posted
  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 Connecticut Children's Medical Center:

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cardiac MRI
    Cardiac MRI
  Eligibility

Ages Eligible for Study:   9 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671696

Locations
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Henry Sweeney    860-545-9981      
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: Olga Salazar, MS Connecticut Childrens Med Ctr
  More Information

No publications provided

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: CardiacMRI
Study First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014