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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Alere San Diego
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01032278
First received: December 13, 2009
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cardiac Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Other: Laboratory Biomarker Analysis
Behavioral: Questionnaires

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 830
Study Start Date: January 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032278

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Lyndon B. Johnson General Hospital (LBJ)
Houston, Texas, United States, 77026
Sponsors and Collaborators
M.D. Anderson Cancer Center
Alere San Diego
Investigators
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01032278     History of Changes
Obsolete Identifiers: NCT01311843
Other Study ID Numbers: CDR0000660615, MDA-2007-0914A, CDR0000660615
Study First Received: December 13, 2009
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
cardiac toxicity
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on July 26, 2014