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RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01719094
First received: October 30, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer, occurring at a significantly younger age than in the general population. The increased incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover, understanding of the mechanisms by which cancer treatment could influence the occurrence of latent cardiovascular events is unavailable. Our group and others have established independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes, cardiac death, and congestive heart failure. The goal of this application is to show that childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health have increased aortic stiffness, when compared to healthy adolescent and young adult age mate. Studies are designed to determine if MRI measures of cardiovascular function differ between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The investigators propose that MRI markers responsible for cardiovascular events represent new clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.


Condition
if Aortic Stiffness
Myocardial Wall Strain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if aortic stiffness changes during treatment with anthracycline chemotherapy in childhood cancer patients [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
    n=25


Estimated Enrollment: 115
Study Start Date: August 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Childhood Cancer Surviviors
Adolescent/young adults with no cancer history
Newly diagnosed cancer patients

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Childhood cancer survivors, adolescent/young adults with no cancer history and newly diagnosed cancer patients

Criteria

Inclusion Criteria:

Childhood Cancer Survivors

  • Diagnosis of cancer at age 21 or younger
  • Current age 16-40 years
  • 1year and ≤ 15 years from end of cancer treatment
  • Received anthracycline chemotherapy
  • Asymptomatic (Appendix VII: absence of palpitations, dyspnea, edema or anginal symptoms)
  • No pre-existing diagnosis with regard to cardiovascular or cerebrovascular disease status.

Adolescent/young adults with no cancer history

  • No prior diagnosis of cancer, diabetes, or lung disease
  • Current age 16-40 years
  • No history of radiation to chest or neck
  • No prior history of chemotherapy
  • Asymptomatic (Appendix VII : absence of palpitations, dyspnea, edema or anginal symptoms) and without a pre-existing diagnosis with regard to cardiovascular or cerebrovascular disease status.

Newly diagnosed cancer patients

  • Diagnosis of cancer at age 25 or younger
  • Current age 7-25 years
  • Planned receipt of anthracycline chemotherapy
  • Planned treatment course ≤ 15 months
  • No pre-existing cardiovascular disease

Exclusion Criteria:

All groups

  • Subjects with implanted electronic devices, including but not limited to: pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
  • Subjects with ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
  • Claustrophobia
  • Subjects who received total body irradiation or cranial irradiation
  • History of acute myocardial infarction
  • Significant ventricular arrhythmias (>20 PVC's/minute due to gating difficulty)
  • Medical history of moderate or severe aortic stenosis, or other significant valvular disease
  • Women who are pregnant
  • Those with pre-existing history (by self report in Group B and review of medical records in addition to self-report for Groups A & C) of abnormal cardiovascular function including: congenital heart disease, hypertension, diabetes, hypercholesterolemia on treatment, a body mass index >35, history of asymptomatic cardiac dysfunction (defined as an ejection fraction < 40 and/or shortening fraction < 28) or symptomatic cardiac dysfunction (congestive heart failure), stroke, renal dysfunction by history/medical records (serum creatinine >1.4), anemia, obstructive or restrictive airways disease
  • Asymptomatic cardiac dysfunction (defined as an ejection fraction < 40 and/or shortening fraction < 28 on last ECHO or MUGA)
  • Participants unwilling to complete the protocol (1 visit for Group A, B; 3 scan studies for Group C)
  • Participants unable to provide informed consent via a guardian or self
  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: NCT01719094

Contacts
Contact: Sharon Castellino, MD 336-716-6724 scastell@wakehealth.edu

Locations
United States, Georgia
Emory University School of Medicine Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Anne Mertens, PhD    404-727-4859    amerten@emory.edu   
Principal Investigator: Anne Mertens, PhD         
United States, North Carolina
Wake Forset University Health Sciences Recruiting
Winston-Salem, NC, North Carolina, United States, 27157
Contact: Shannon Golden    336-716-7537    sgolden@wakehealth.edu   
Principal Investigator: Sharon Castellino, MD         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Sharon M Castellino, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01719094     History of Changes
Other Study ID Numbers: CCCWFU 99312
Study First Received: October 30, 2012
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014