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No funding, no participation
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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop AIC.
Plan is to enroll 110 children and adults (≥9 years old) newly diagnosed at CCMC and Nationwide Children's Hospital (55 per institution) who will receive anthracyclines as part of their chemotherapy regimen.
The duration of study participation will be approximately a year.
Patients will have a total of four study visits:
Baseline
1 week after patient's anthracycline cumulative dose hits between 60 and 100 mg/m2 After the patient has completed maximal therapy One year after completion of anthracycline treatments
Study tasks for all four visits will be:
Collection of clinical data Blood draw for micro RNA and Biomarkers Cardiac MRI Echocardiogram One time blood draw for genetics
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI | Other | Patients will have a cardiac MRI at four time points during the study |
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| Echocardiogram | Other | Patients will have an echocardiogram at four time points during the study |
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| Blood Draw | Other | Patients will have blood drawn at four time points to analyze micro RNAs and Biomarkers before, during and after anthracycline treatment. Patients will also have one blood draw for future genetic sequencing. |
| Measure | Description | Time Frame |
|---|---|---|
| CMR | 1. Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique | From Baseline to one year after anthracycline therapy |
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Inclusion Criteria:
Exclusion Criteria:
Age (years) Male Female 6-10 1.0 mg/dL 1.0 mg/dL 10-13 1.2 mg/dL 1.2 mg/dL 13-16 1.5 mg/dL 1.4 mg/dL >16 1.7 mg/dL 1.4 mg/dL
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Patients who are > or equal to 9 years of age who are newly diagnosed with cancer who will receive anthracycline (s) as part of the their treatment regimen.
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| Name | Affiliation | Role |
|---|---|---|
| Olga Salazar, MD | Connecticut Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olga Salazar | Hartford | Connecticut | 06106 | United States |
Pending
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059552 | Caves |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D055593 | Geological Phenomena |
| D055585 | Physical Phenomena |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
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pending
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |