Cardiac ToxicityNCT01032278
Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)
A study testing Laboratory Biomarker Analysis and Questionnaires in people with Cardiac Toxicity and Unspecified Adult Solid Tumor, Protocol Specific, run by M.D. Anderson Cancer Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Laboratory Biomarker Analysis and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2011to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital (LBJ)
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
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)
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.
Read the detailed 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.
- Being tested
- Laboratory Biomarker Analysis, Questionnaires
- Keywords
- cardiac toxicity, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Also called Biomarker Testing
Blood drawn for biomarker analysis at baseline, before each chemotherapy visit, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.
QuestionnairesBehavioural
Also called Survey
Symptom questionnaire completion at baseline, beginning of every third cycle of chemotherapy, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Biomarker Testing | Experimental | Biomarker testing for cardiac biomarkers, B-type natriuretic peptide (BNP) and Troponin I (TnI), and symptom questionnaires of participants undergoing anthracycline-based chemotherapy. Receives: Other: Laboratory Biomarker Analysis; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity
Measured: 12 months
Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy
Measured: 12 months
Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study start25 Jan 2011
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ToxicityStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alere San Diego
- Responsible party
- Sponsor
- Investigators
- Robert A. Wolff, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032278
- Sponsor's protocol ID
- CDR0000660615
- Other IDs
- MDA-2007-0914A, CDR0000660615, NCI-2011-01466
- Status last verified
- May 2019
- First submitted
- 13 Dec 2009
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Narayan HK, Wei W, Feng Z, Lenihan D, Plappert T, Englefield V, Fisch M, Ky B. Cardiac mechanics and dysfunction with anthracyclines in the community: results from the PREDICT study. Open Heart. 2017 Jan 16;4(1):e000524. doi: 10.1136/openhrt-2016-000524. eCollection 2017.
PubMed 28123764
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01032278
- Acronym / sponsor ID
- CDR0000660615
- Keywords
- cardiac toxicity, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 597 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Alere San Diego
- Study start
- 25 Jan 2011 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Biomarker Testing | Experimental | Other: Laboratory Biomarker Analysis, Behavioral: QuestionnairesBiomarker testing for cardiac biomarkers, B-type natriuretic peptide (BNP) and Troponin I (TnI), and symptom questionnaires of participants undergoing anthracycline-based chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisAlso: Biomarker TestingBlood drawn for biomarker analysis at baseline, before each chemotherapy visit, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy. | Other | Cardiac Biomarker Testing |
| QuestionnairesAlso: SurveySymptom questionnaire completion at baseline, beginning of every third cycle of chemotherapy, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy. | Behavioural | Cardiac Biomarker Testing |
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 28123764Narayan HK, Wei W, Feng Z, Lenihan D, Plappert T, Englefield V, Fisch M, Ky B. Cardiac mechanics and dysfunction with anthracyclines in the community: results from the PREDICT study. Open Heart. 2017 Jan 16;4(1):e000524. doi: 10.1136/openhrt-2016-000524. eCollection 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A. Wolff, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis and Questionnaires in people with Cardiac Toxicity and Unspecified Adult Solid Tumor, Protocol Specific, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.