Radiation Therapy and Cardiac Enzymes
Tracking Information | |||||
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First Received Date ICMJE | October 21, 2008 | ||||
Last Updated Date | September 5, 2012 | ||||
Start Date ICMJE | October 2008 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Elevation in cardiac biomarkers by measuring cardiac troponins (troponin T and troponin I), BNP, and CK-MB. [ Time Frame: 4 Time Points: within 1 week prior to radiation therapy (RT), within 1-3 days of RT completion, and at 1 and 3 months after completion of RT. ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
To learn if radiation doses result in increased cardiac biomarkers. [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00777751 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Radiation Therapy and Cardiac Enzymes | ||||
Official Title ICMJE | Radiation Therapy and Cardiac Biomarkers | ||||
Brief Summary | The goal of this clinical research study is to learn if the radiation that you are receiving will result in an increase in certain proteins produced by the heart called cardiac biomarkers. |
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Detailed Description | Cardiac Biomarkers: Cardiac biomarkers are proteins made by the heart. When cardiac biomarkers are above normal levels, there may be damage to the heart. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy. How cardiac biomarkers can play a role in predicting future heart problems during radiation therapy will also be studied. Study Tests: If you agree to take part in this study, blood (about 1 teaspoon) will be drawn to measure certain cardiac biomarkers up to 2 days before radiation therapy, following the first treatment of radiation, within 2 days of finishing radiation therapy, and about 1 to 2 months after completion of radiation therapy. Once the blood testing is completed, any leftover blood samples will be destroyed. You will also have electrocardiograms (ECGs -- tests that measure the electrical activity of the heart) at the same time points as the blood draws. Length of Study: You will be off study after the last blood draw and ECG. This is an investigational study. Up to 30 patients will be enrolled in this study. All will be enrolled at M. D. Anderson. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients with tumors in the chest in close proximity to the heart, including histologically proven primary lung cancer, esophageal cancer, or thymoma, to be treated with single modality RT. |
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Condition ICMJE | Tumor | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 30 | ||||
Completion Date | |||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00777751 | ||||
Other Study ID Numbers ICMJE | 2007-0489 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |