Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)

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.

At each chemotherapy visit, before you receive your chemotherapy the following tests and
procedures will be performed:

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Additional blood (about 1 teaspoon) will be drawn for biomarker testing.

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:

- You will complete the symptom questionnaire.

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Additional blood (about 1 teaspoon) will be drawn for biomarker testing.

- You will have an ECG.

- You will have an echocardiogram or MUGA.

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:

- You will complete the symptom questionnaire.

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Additional blood (about 1 teaspoon) will be drawn for biomarker testing.

- You will have an ECG.

- You will have an echocardiogram or MUGA.

At any time during the study, if your doctor thinks it is necessary, you will have an ECG
and/or echocardiogram or MUGA.

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.

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.

Inclusion Criteria:

1. Patient age 18-85 years

2. Starting a new course of chemotherapy that includes an anthracycline (does not have
to be first-line therapy and previous anthracycline use is allowed)

3. Has a life expectancy greater than 12 months

Exclusion Criteria:

1. Unstable angina within the last 3 months of registration

2. Myocardial infarction within the last 3 months of registration

3. LVEF less than 50%

4. Patients receiving concurrent dexrazoxane

5. Decompensated Heart Failure in the last 3 months prior to registration

6. Prior symptomatic arrhythmia (within 3 months of study registration)

7. Severe pulmonary disease (FEV pulmonary artery pressure >/=60mm Hg), and/or dependent use of oxygen

8. BNP >/= 200 pg/ml or troponin I >/= 0.4 ng/ml via use of the Biosite Triage Profiler
Note: BNP and/or TnI resulted in a local lab within 30 days of starting anthracycline
based chemotherapy may be used in determining eligibility. Results, either by the
Biosite Triage Profiler or the local lab, >/= the parameters described deem the
patient ineligible for participation in this study