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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01032278
• Other study ID #: CDR0000660615
• Secondary ID: MDA-2007-0914ACD
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 25, 2011
• Est. completion date: January 2021

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

• You will have an ECHO or MUGA scan.

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 ECHO or MUGA scan.

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

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.

Research Test Results:

The primary biomarkers being tested in this study are the BNP and TnI. Both the BNP and TnI look at the function of your heart. The BNP and TnI will both be tested at MD Anderson.

The results of the biomarker tests will be kept separately from your other tests results, and will not affect your treatment in any way. The only reason your biomarker test results would be shared with your cancer doctor would be if the study doctor thinks the results show a heart problem. In that case, the study doctor will contact you right away to advise you about what to do next (for example, coming in to the clinic). You will be referred to a cardiologist (heart doctor) if the study doctor decides it is necessary.

In addition to the biomarkers being tested in this study, if you had ECHOs during the study, the images of the ECHOs may be copied to a DVD and sent to the University of Pennsylvania for review related to research on heart damage caused by anthracycline-based chemotherapy. Before sending your ECHOs to the University of Pennsylvania MD Anderson will remove all of your personal identifiers (name, date of birth, age, and medical record number) included on the ECHO imaging DVD.

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. Up to 200 will be enrolled at the Harris Health System and MD Anderson.

Other known NCT identifiers

• NCT01311843

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 597
• Est. completion date: January 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient age 18 years or older

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 </= 1.0 liters), and/or pulmonary hypertension (mean pulmonary artery pressure >/=60mm Hg), and/or dependent use of oxygen

8. 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

Related Conditions & MeSH terms

• Cardiac Toxicity
• Cardiotoxicity
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

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.

Behavioral:
• Questionnaires
Symptom questionnaire completion at baseline, beginning of every third cycle of chemotherapy, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.

Locations

Country	Name	City	State
United States	Lyndon B. Johnson General Hospital (LBJ)	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Alere San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Cardiac Biomarkers, B-type Natriuretic Peptide (BNP) and Troponin I (TnI), for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-based Chemotherapy	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.	12 months
Secondary	Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity		12 months
Secondary	Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy		12 months
Secondary	Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity		12 months

External Links

•   University of Texas MD Anderson Cancer Center Website