Clinical Trial: Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicenter Study in Patients Undergoing AnthRacycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Descr
Brief Summary: 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.
Detailed Summary:
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:
- 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. Sponsor: M.D. Anderson Cancer Center
- Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity [ Time Frame: 12 months ]
- Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy [ Time Frame: 12 months ]
- Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity [ Time Frame: 12 months ]
- Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity
- Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy
- Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity
Current Primary Outcome: Use of Cardiac Biomarkers, B-type Natriuretic Peptide (BNP) and Troponin I (TnI), for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-based Chemotherapy [ Time Frame: 12 months ]
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.
Original Primary Outcome: Sensitivity and specificity of cardiac biomarkers in detecting cardiotoxicity within 12 months of initiation of anthracycline-based chemotherapy
Current Secondary Outcome:
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: December 13, 2009
Date Started: January 25, 2011
Date Completion: January 1, 2018
Last Updated: January 27, 2017
Last Verified: January 2017
