Studying Biomarkers in Detecting Heart Damage in Patients Receiving Chemotherapy
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Purpose
RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors identify and learn more about biomarkers related to heart damage due to chemotherapy. It may also help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how well biomarkers work in detecting heart damage in patients receiving chemotherapy.
| Condition | Intervention |
|---|---|
|
Cardiac Toxicity Unspecified Adult Solid Tumor, Protocol Specific |
Drug: Systemic chemotherapy Other: Laboratory biomarker analysis Other: Questionnaire administration |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment |
- Sensitivity and specificity of cardiac biomarkers in detecting cardiotoxicity within 12 months of initiation of anthracycline-based chemotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Biomarker Testing
Biomarker testing of participants undergoing anthracycline-based chemotherapy
|
Drug: Systemic chemotherapy
Other: Laboratory biomarker analysis
Other Name: Biomarker Testing
Other: Questionnaire administration
Other Names:
|
Detailed Description:
OBJECTIVES:
Primary
- To assess the sensitivity and specificity of cardiac biomarkers, specifically B-type natriuretic peptide (BNP) and troponin I, in detecting cardiotoxicity in patients undergoing anthracycline-based chemotherapy.
Secondary
- To define the sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity.
- To describe the clinical management and outcomes of patients identified with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy.
- To confirm the supportive utility of patient-reported symptoms for the development of cardiac-related toxicity.
OUTLINE: This is a multicenter study.
Patients receive anthracycline-based chemotherapy for approximately 8 courses.
Patients undergo physical exam, ECHO, EKG, and laboratory assessments, including measurement of B-type natriuretic peptide (BNP) and troponin I biomarkers, at baseline and periodically for up to 12 months. Patients also complete the M.D. Anderson Symptom Index-Heart Failure questionnaire at baseline and periodically for up to 12 months. Patients with an identified cardiac event, suspected cardiotoxicity, or abnormal biomarkers are referred to a cardiologist for treatment.
After completion of chemotherapy, patients are followed up at 6 and 12 months.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planning to start a new course of chemotherapy that includes an anthracycline
- Does not have to be first-line therapy
- B-type natriuretic peptide (BNP) < 200 pg/mL
- Troponin I < 0.4 ng/mL
PATIENT CHARACTERISTICS:
- Life expectancy > 12 months
- Left ventricular ejection fraction (LVEF) ≥ 50%
- No unstable angina within the past 3 months
- No myocardial infarction within the past 3 months
- No decompensated heart failure within the past 3 months
- No pre-existing or prior symptomatic arrhythmia within the past 3 months
- No severe pulmonary disease (FEV ≤ 1.0 L)
- No pulmonary hypertension (mean pulmonary artery pressure ≥ 60 mm Hg)
- Not dependent on oxygen
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior anthracyclines allowed
- No concurrent dexrazoxane
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center 713-792-3245 | |
| 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 |
| Other Study ID Numbers: | CDR0000660615, MDA-2007-0914A, CDR0000660615 |
| Study First Received: | December 13, 2009 |
| Last Updated: | November 20, 2012 |
| 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 May 19, 2013