Studying Biomarkers in Detecting Heart Damage in Patients Receiving Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01032278
First received: December 13, 2009
Last updated: May 22, 2013
Last verified: May 2013

December 13, 2009
May 22, 2013
January 2011
December 2014   (final data collection date for primary outcome measure)
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 cardiac biomarkers in detecting cardiotoxicity within 12 months of initiation of anthracycline-based chemotherapy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01032278 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity [ Designated as safety issue: No ]
  • Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy [ Designated as safety issue: No ]
  • Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Studying Biomarkers in Detecting Heart Damage in Patients Receiving Chemotherapy
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cardiac Toxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: Systemic chemotherapy
  • Other: Laboratory biomarker analysis
    Other Name: Biomarker Testing
  • Other: Questionnaire administration
    Other Names:
    • Survey
    • Questionnaire
Experimental: Biomarker Testing
Biomarker testing of participants undergoing anthracycline-based chemotherapy
Interventions:
  • Drug: Systemic chemotherapy
  • Other: Laboratory biomarker analysis
  • Other: Questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
830
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01032278
CDR0000660615, MDA-2007-0914A, CDR0000660615
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP