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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)


N/A
18 Years
85 Years
Open (Enrolling)
Both
Breast Cancer, Gastrointestinal Cancer, Genitourinary Cancer, Leukemia, Lung Cancer

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Trial Information

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)


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. This same
blood will be used for future research to explore other biomarkers, including genetic
predictors that may be related to heart failure.

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. This same
blood will be used for future research to explore other biomarkers, including genetic
predictors that may be related to heart failure.

- You will have an ECG.

- You will have an echocardiogram or MUGA.

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. This same
blood will be used for future research to explore other biomarkers, including genetic
predictors that may be related to heart failure.

- You will have an ECG.

- You will have an echocardiogram or MUGA.

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

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 biomarker being tested in this study is the BNP. The BNP looks at the function
of your heart. The BNP will be tested at MD Anderson.

Another biomarker test that looks at the function of your heart is the Troponin I (TnI). At
this time, the devices to test the TnI are not available, but if the devices become
available any time during the 12 months you are on the study, your TnI will be tested along
with to test the BNP and the TnI, so no extra blood will be needed.

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.

After testing the BNP alone or testing both the BNP and TnI, any leftover blood that has
been collected during the 12 months of your participation on this study will be stored in an
outside research samples bank for use in future research related to heart failure. The
blood sample will be processed to separate the plasma from the blood cells.

The research samples will be sent to a blood bank at Vanderbilt University Medical
Center-Cardiology Core Lab in Nashville, Tennessee, for use in future research related to
heart failure. There are no plans to share any findings with you. The research samples
will be used until they are gone or are no longer useful for research and are destroyed by
the laboratory.

Before your blood is sent to Vanderbilt University Medical Center - Cardiology Core Lab for
testing, your name and any personal identifying information will be coded to protect your
privacy. Each part of the research sample will be labeled with a unique code assigned by
the research staff. None of your personal identifying information will be used when
labeling the tubes. The study doctor and his research staff will be the only ones able to
link the unique code to you or any of your personal identifying information. The Vanderbilt
University Medical Center - Cardiology Core will not have access to the codes that link the
samples to your identity.

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
MD Anderson.


Inclusion Criteria:



1. Patient age 18-85 years

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 pulmonary artery pressure >/=60mm Hg), and/or dependent use of oxygen

8. BNP >/= 200 pg/ml or troponin I >/= 0.4 ng/ml via use of the Biosite Triage Profiler
Note: BNP and/or 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 deem the
patient ineligible for participation in this study

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Cardiac Biomarkers for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-Based Chemotherapy

Outcome Description:

Biomarkers (BNP and Troponin I) obtained from lab test using BIOCIST before each chemotherapy cycle. A small sample of blood taken at baseline and at each scheduled chemotherapy visit prior to receiving chemotherapy and spun at 10,000 rpm for 10 minutes.

Outcome Time Frame:

Baseline and before each chemotherapy treatment, observation period up to 12 months

Safety Issue:

No

Principal Investigator

Michael Fisch, MD,MPH

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0914

NCT ID:

NCT01311843

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Gastrointestinal Cancer
  • Genitourinary Cancer
  • Leukemia
  • Lung Cancer
  • anthRacycline-based chemotherapy
  • Cardiac Biomarkers
  • Cardiotoxicity
  • Lymphoma
  • Melanoma
  • Myeloma
  • Sarcoma
  • M. D. Anderson Symptom Index Heart Failure
  • MDASI-HF
  • questionnaire
  • Breast Neoplasms
  • Leukemia
  • Lung Neoplasms
  • Gastrointestinal Neoplasms
  • Urogenital Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
M.D. Anderson CCOP Network SitesHouston, Texas  77030
Lyndon B. Johnson General Hospital (LBJ)Houston, Texas  77030