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:
NCT01311843
First received: March 7, 2011
Last updated: April 3, 2014
Last verified: April 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
Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Leukemia
Lung Cancer
Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:
  • Cardiac Biomarkers for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-Based Chemotherapy [ Time Frame: Baseline and before each chemotherapy treatment, observation period up to 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • B-type Natriuretic Peptide (BNP) Biomarkers for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-Based Chemotherapy [ Time Frame: Baseline and before each chemotherapy treatment, observation period up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Troponin I Biomarkers for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-Based Chemotherapy [ Time Frame: Baseline and before each chemotherapy treatment, observation period up to 12 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood (about 1 teaspoon) drawn for biomarker testing.


Estimated Enrollment: 830
Study Start Date: January 2011
Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Biomarker Testing
Biomarker Testing + Symptom Questionnaires in Anthracycline-Based Chemotherapy Group
Other: Questionnaire
Symptom questionnaires at beginning of every third cycle of chemotherapy, and at about month 6 (follow-up visit) and at about month 12 (end-of study visit).
Other Names:
  • Survey
  • MDASI
  • M. D. Anderson Symptom Index - Heart Failure
  • MDASI-HF

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants, age 18 years and above, starting at new chemotherpy course at UT MD Anderson Cancer Clinics and Community Programs (CCOP/Network), and Lyndon B. Johnson General Hospital Cancer Clinics.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311843

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
M.D. Anderson CCOP Network Sites
Houston, Texas, United States, 77030
Lyndon B. Johnson General Hospital (LBJ)
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Alere San Diego
Investigators
Study Chair: Michael Fisch, MD,MPH UT MD Anderson Cancer Center
Study Chair: Daniel J. Lenihan, MD Vanderbilt University, Division of Cardiovascular Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01311843     History of Changes
Other Study ID Numbers: 2007-0914
Study First Received: March 7, 2011
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
anthRacycline-based chemotherapy
Cardiac Biomarkers
Cardiotoxicity
Lymphoma
Melanoma
Myeloma
Sarcoma
M. D. Anderson Symptom Index Heart Failure
MDASI-HF
questionnaire

Additional relevant MeSH terms:
Breast Neoplasms
Leukemia
Lung Neoplasms
Gastrointestinal Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014