Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT01719094
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT01719094
Study Brief:
Protocol Section:
NCT01719094