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Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Oncology | Family Medicine
Disease Category: Cancer Treatment
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

MDA 2007-0194A Studying Biomarkers in Detecting Heart Damage in Patients Receiving Chemotherapy

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

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

Patient Inclusion Criteria:

  • Patients receive anthracycline-based chemotherapy for approximately 8 courses.
  • Ages Eligible for Study: 18 Years to 85 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No
  • 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
  • Life expectancy > 12 months
  • LVEF ≥ 50%

Patient Exclusion Criteria:

  • 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

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 to 85 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183160

Date Last Changed: July 17, 2013


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