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

Status unconfirmed · Not applicable

Conditions studied: Cardiac Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT01032278

Run by

M.D. Anderson Cancer Center

People needed

597

Starts

2011-01-25

Expected to finish

2021-01-01

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age 18 years or older
• Starting a new course of chemotherapy that includes an anthracycline (does not have to be first-line therapy and previous anthracycline use is allowed)
• Has a life expectancy greater than 12 months

You may not qualify if…

• Unstable angina within the last 3 months of registration
• Myocardial infarction within the last 3 months of registration
• LVEF less than 50%
• Patients receiving concurrent dexrazoxane
• Decompensated Heart Failure in the last 3 months prior to registration
• Prior symptomatic arrhythmia (within 3 months of study registration)
• Severe pulmonary disease (FEV </= 1.0 liters), and/or pulmonary hypertension (mean pulmonary artery pressure >/=60mm Hg), and/or dependent use of oxygen
• BNP >/= 200 pg/ml or BNP >/= 200 pg/ml and troponin I >/= 0.4 ng/ml via use of the Biosite Triage Profiler Note: BNP or BNP and 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 in exclusion 3.2.8 deem the patient ineligible for participation in this study

Where it is running

• Lyndon B. Johnson General Hospital (LBJ) — Houston, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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