Markers of Anthracycline-Related Cardiac Muscle Injury
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Purpose
Anthracycline antibiotics are included in the chemotherapy regimens of approximately 82% of patients with bone cancer and 44% of those with soft tissue sarcoma diagnosed in childhood or adolescence. Impaired cardiac function occurs after treatment with anthracyclines. The frequency of impairment increases with increasing cumulative dose. There are inadequate data regarding the relationship between doxorubicin administration and changes in serum levels of cardiac troponin T (cTn-T) or I (cTn-I), N-terminal (NT) brain natriuretic peptide (BNP), or tissue Doppler imaging parameters.
This non-therapeutic study proposes a prospective, single arm study of serial changes in tissue Doppler imaging parameters, cTn-T and NT-BNP in children and adolescents with malignant bone and soft tissue tumors whose planned chemotherapy includes treatment with ≥ 375 mg/m2 of doxorubicin.
The proposed study will rigorously evaluate the usefulness of serial determinations of tissue Doppler imaging, cTn-T and NT-BNP for very early identification of anthracycline-related myocardial injury. Demonstration that one or more of these markers identifies subclinical myocardial damage and that biomarker or tissue Doppler imaging parameters exhibit a dose-response relationship with cumulative doxorubicin dose would facilitate intervention trials in patients at risk for anthracycline cardiomyopathy.
| Condition |
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Osteosarcoma Ewing's Sarcoma Family of Tumors Rhabdomyosarcoma Non-rhabdomyosarcoma Soft Tissue Sarcomas |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Markers of Anthracycline-Related Cardiac Muscle Injury |
- Imaging measurement of potential cardiac muscle injury markers before and after cumulative anthracycline exposure. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]This study will serially evaluate imaging tests in previously untreated patients with osteosarcoma, Ewing's sarcoma family of tumors, rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes a cumulative doxorubicin dose ≥ 375 mg/m2 to determine if serial levels of one or more of these potential markers of cardiac muscle injury obtained prior to each infusion of doxorubicin and at the completion of chemotherapy correlate with increasing cumulative anthracycline exposure.
Biospecimen Retention: Samples Without DNA
A blood sample will be collected at baseline, prior to and at the end of each doxorubicin infusion (48- or 72-hour) and following completion of chemotherapy for osteosarcoma, ESFT, rhabdomyosarcoma or intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas.cTn-T and NT-BNP will be measured at baseline, prior to and at the end of each doxorubicin infusion (48- or 72-hour) and following completion of chemotherapy for osteosarcoma, ESFT, rhabdomyosarcoma or intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas.
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Participants
Previously untreated patients referred to St. Jude Children's Research Hospital (SJCRH) between the ages of 0 and 21 years with a diagnosis of osteosarcoma, ESFT, rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes administration of a cumulative anthracycline dose ≥ 375 mg/m2.
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Detailed Description:
The primary aim of this proposal is to serially evaluate imaging tests in previously untreated patients with osteosarcoma, Ewing's Sarcoma Family of Tumors(ESFT), rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes a cumulative doxorubicin dose ≥ 375 mg/m2 to determine if serial levels of one or more of these potential markers of cardiac muscle injury obtained prior to each infusion of doxorubicin and at the completion of chemotherapy correlate with increasing cumulative anthracycline exposure.
The secondary aim of the study is to estimate the proportion of patients with decreased (evaluation j - evaluation j+1) peak longitudinal systolic strain (ε) or strain rate (SR), peak radial systolic ε or SR, peak radial systolic myocardial velocity or peak longitudinal systolic myocardial velocity among those who have a shortening fraction (SF) ≥ 29% prior to each infusion of anthracycline. This study will evaluate whether the serum levels of cTn-T and/or NT-BNP will increase following doxorubicin administration. The study will evaluate whether the serum levels of cTn-T and/or NT-BNP will increase with increasing cumulative doxorubicin dose.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Previously untreated patients referred to St. Jude Children's Research Hospital (SJCRH) between the ages of 0 and 21 years with a diagnosis of osteosarcoma, ESFT, rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes administration of a cumulative anthracycline dose ≥ 375 mg/m2.
Inclusion Criteria:
- Between 0 and 21 years of age
- Diagnosis of osteosarcoma, Ewing Sarcoma Family of Tumors, rhabdomyosarcoma, or intermediate or high-risk non-rhabdomyosarcoma soft tissue sarcoma
- Planned treatment includes administration of a cumulative anthracycline dose ≥ 375 mg/m2
Exclusion Criteria:
- Pregnant Females
- Patients with a history of cancer prior to the current malignancy
- Patients whose treatment will include radiation therapy to a volume that will include the heart
Contacts and Locations| Contact: Daniel Green, MD | 1-866-278-5833 | info@stjude.org |
| United States, Tennessee | |
| St . Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Daniel Green, MD 866-278-5833 info@stjude.org | |
| Principal Investigator: Daniel Green, MD | |
| Principal Investigator: | Daniel Green, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01112800 History of Changes |
| Other Study ID Numbers: | MARCI |
| Study First Received: | April 26, 2010 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Jude Children's Research Hospital:
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Anthracycline Cardiac Muscle Injury Doxorubicin |
Doppler Imaging Intermediate non-rhabdomyosarcoma soft tissue sarcomas High-risk non-rhabdomyosarcoma soft tissue sarcomas |
Additional relevant MeSH terms:
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Osteosarcoma Rhabdomyosarcoma Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Myosarcoma Neoplasms, Muscle Tissue Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013