| ID | Type | Description | Link |
|---|---|---|---|
| MDA-2007-0914A | |||
| CDR0000660615 | Other Identifier | NCI Clinical Trials | |
| NCI-2011-01466 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Alere San Diego | INDUSTRY |
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The goal of this clinical research study is to learn if certain biomarker testing on blood samples can help to detect heart damage that may occur during chemotherapy. Biomarkers are chemical "markers" found in the blood that may be related to heart function. High levels of these markers may be linked with heart problems such as heart damage.
Study Visits:
If you are found to be eligible to take part in this study, you will have study tests and procedures performed on the same days as your visits for chemotherapy treatment. These study visits will occur about every 3-4 weeks apart. The exact number and timing of the visits will depend on when your scheduled chemotherapy visits occur. You and your doctor will discuss the best chemotherapy treatment and schedule for you.
At each chemotherapy visit, before you receive your chemotherapy the following tests and procedures will be performed:
At the beginning of every third cycle of chemotherapy you will be asked to complete a questionnaire about any symptoms you may be experiencing.
Follow-Up Visit:
At about 6 months after starting your chemotherapy the following tests and procedures will be performed:
End-of-Study Visit:
At about 12 months after starting your chemotherapy you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
At any time during the study, if your doctor thinks it is necessary, you will have an ECG and/or ECHO or MUGA scan.
If you stop receiving chemotherapy during your participation in this study, you will still be asked to complete the above tests and procedures listed at the 12-month (end-of-study visit) visit. Other tests and procedures scheduled during the study may not be performed because you are no longer receiving chemotherapy treatment. Your study doctor and the research staff will go over this information with you if this happens.
Research Test Results:
The primary biomarkers being tested in this study are the BNP and TnI. Both the BNP and TnI look at the function of your heart. The BNP and TnI will both be tested at MD Anderson.
The results of the biomarker tests will be kept separately from your other tests results, and will not affect your treatment in any way. The only reason your biomarker test results would be shared with your cancer doctor would be if the study doctor thinks the results show a heart problem. In that case, the study doctor will contact you right away to advise you about what to do next (for example, coming in to the clinic). You will be referred to a cardiologist (heart doctor) if the study doctor decides it is necessary.
In addition to the biomarkers being tested in this study, if you had ECHOs during the study, the images of the ECHOs may be copied to a DVD and sent to the University of Pennsylvania for review related to research on heart damage caused by anthracycline-based chemotherapy. Before sending your ECHOs to the University of Pennsylvania MD Anderson will remove all of your personal identifiers (name, date of birth, age, and medical record number) included on the ECHO imaging DVD.
Length of Study Participation:
Your study participation will last about 12 months from date of your first chemotherapy treatment. You will have a follow up visit at about 6 months from the date of your first chemotherapy and an end of study visit at about 12 months from the date of your first chemotherapy treatment. This will end your participation in the study.
This is an investigational study. At this time, the biomarker testing in this study is only being used in research. Its use in detecting heart damage is considered investigational.
Up to 830 patients will take part in this multicenter study. Up to 200 will be enrolled at the Harris Health System and MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Biomarker Testing | Experimental | Biomarker testing for cardiac biomarkers, B-type natriuretic peptide (BNP) and Troponin I (TnI), and symptom questionnaires of participants undergoing anthracycline-based chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Blood drawn for biomarker analysis at baseline, before each chemotherapy visit, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Cardiac Biomarkers, B-type Natriuretic Peptide (BNP) and Troponin I (TnI), for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-based Chemotherapy | Cardiotoxicity defined as presentation of one or more cardiac events within 12 months of initiation of chemotherapy. Cardiac event defined as any new symptomatic cardiac arrhythmia, acute coronary syndrome, symptomatic HF, development of asymptomatic left ventricular dysfunction (defined as left ventricular ejection fraction (LVEF) reduction of 10% to less than 50% or a decrease of greater than 15% from baseline), or sudden cardiac death (defined as rapid and unexpected death from cardiac causes with or without known underlying heart disease). BNP greater than 200 pg/ml is considered abnormal. Troponin I greater than 0.4 ng/ml is also considered abnormal. Patients having at least one abnormal evaluation preceding cardiotoxicity for either biomarker (i.e., one abnormal troponin or one abnormal BNP assessments) classified as having an abnormal test. Primary analysis performed using data from all subjects with at least one post baseline biomarker measure for BNP and/or troponin I. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity | 12 months | |
| Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert A. Wolff, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson General Hospital (LBJ) | Houston | Texas | 77026 | United States | ||
| University of Texas MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28123764 | Derived | Narayan HK, Wei W, Feng Z, Lenihan D, Plappert T, Englefield V, Fisch M, Ky B. Cardiac mechanics and dysfunction with anthracyclines in the community: results from the PREDICT study. Open Heart. 2017 Jan 16;4(1):e000524. doi: 10.1136/openhrt-2016-000524. eCollection 2017. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Questionnaires | Behavioral | Symptom questionnaire completion at baseline, beginning of every third cycle of chemotherapy, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy. |
|
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| Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity | 12 months |
| Houston |
| Texas |
| 77030-4009 |
| United States |
| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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