A Multicenter Study in Patients Undergoing AnthRacycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)
试验速览
- 阶段
- 不适用
- 入组人数
- 597
- 试验地点
- 4
- 主要终点
- Use of Cardiac Biomarkers, B-type Natriuretic Peptide (BNP) and Troponin I (TnI), for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-based Chemotherapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cardiac Biomarker Testing
Biomarker testing for cardiac biomarkers, B-type natriuretic peptide (BNP) and Troponin I (TnI), and symptom questionnaires of participants undergoing anthracycline-based chemotherapy.
干预措施: Laboratory Biomarker Analysis (Other)
Cardiac Biomarker Testing
Biomarker testing for cardiac biomarkers, B-type natriuretic peptide (BNP) and Troponin I (TnI), and symptom questionnaires of participants undergoing anthracycline-based chemotherapy.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Use of Cardiac Biomarkers, B-type Natriuretic Peptide (BNP) and Troponin I (TnI), for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-based Chemotherapy
时间窗: 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.
次要结局
- 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)
- Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity(12 months)