Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to A… (NCT01671696) | Clinical Trial Compass
CompletedNot Applicable
Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy
United States80 participantsStarted 2011-11-15
Plain-language summary
The main hypothesis being tested is that magnetic resonance imaging and serologic biomarkers of apoptosis and 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.
Who can participate
Age range
9 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
5.1 A. Subject Inclusion Criteria
* Childhood cancer survivors from the late effect clinic who had received ≥240 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 2 years.
* Age \> 9 years of age\*
* Parental/caregiver consent and subject assent to enrollment
\* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation B. Subject Inclusion Criteria
* Enrolled in part A of the study, which took place from October 2011 to July 2013.
* Parental/caregiver consent and subject assent to enrollment C. Subject Inclusion Criteria
* Childhood cancer survivors from the late effect clinic who had received \< 300 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 1 year
* Age ≥ 9 years of age\*
* Parental/caregiver consent and subject assent to enrollment
* \* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation
5.2 A. Subject Exclusion Criteria
* Contraindications to CMRI.\*
* Pregnancy\*\*
\* Contraindications to CMRI (i.e., magnetically activated implants/devices; cardiac pacemaker or wires; after the patients are scheduled for CMRI, they will be sent our standard pre-MRI paperwork/questionnaire, to determine eligibility to have an MRI)
\*\*If a female patient of child bearing age is not sure if they are pregnant or not, as part of the standard CMRI with contrast procedures, a urine pregnancy test will be done. If the result is positive the s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To see if a CMRI is better at detecting occult asymptomatic cardiotoxicity