Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)
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|ClinicalTrials.gov Identifier: NCT01032278|
Recruitment Status : Active, not recruiting
First Posted : December 15, 2009
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Toxicity Unspecified Adult Solid Tumor, Protocol Specific||Other: Laboratory Biomarker Analysis Behavioral: Questionnaires||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||597 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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)|
|Actual Study Start Date :||January 25, 2011|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: 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.
Other: Laboratory Biomarker Analysis
Blood drawn for biomarker analysis at baseline, before each chemotherapy visit, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.
Other Name: Biomarker Testing
Symptom questionnaire completion at baseline, beginning of every third cycle of chemotherapy, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.
Other Name: Survey
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032278
|United States, Texas|
|Lyndon B. Johnson General Hospital (LBJ)|
|Houston, Texas, United States, 77026|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Robert A. Wolff, MD||M.D. Anderson Cancer Center|