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

NCT01032278 | Unknown DMC

• 3 other identifiers: CDR0000660615MDA-2007-0914ANCI-2011-01466
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Toxicity; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

cardiac toxicity; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Use of Cardiac Biomarkers, B-type Natriuretic Peptide (BNP) and Troponin I (TnI), for Detecting Cardiotoxicity in Patients Undergoing Anthracycline-based Chemotherapy

  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.

  12 months

Secondary Outcomes (3)

• Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity

  12 months

• Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy

  12 months

• Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity

  12 months

Study Arms (1)

Cardiac Biomarker Testing

EXPERIMENTAL

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; Behavioral: Questionnaires

Interventions

Laboratory Biomarker Analysis OTHER

Blood drawn for biomarker analysis at baseline, before each chemotherapy visit, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.

Also known as: Biomarker Testing

Cardiac Biomarker Testing

Questionnaires BEHAVIORAL

Symptom questionnaire completion at baseline, beginning of every third cycle of chemotherapy, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.

Also known as: Survey

Cardiac Biomarker Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18 years or older
• Starting a new course of chemotherapy that includes an anthracycline (does not have to be first-line therapy and previous anthracycline use is allowed)
• Has a life expectancy greater than 12 months

You may not qualify if:

• Unstable angina within the last 3 months of registration
• Myocardial infarction within the last 3 months of registration
• LVEF less than 50%
• Patients receiving concurrent dexrazoxane
• Decompensated Heart Failure in the last 3 months prior to registration
• Prior symptomatic arrhythmia (within 3 months of study registration)
• Severe pulmonary disease (FEV \</= 1.0 liters), and/or pulmonary hypertension (mean pulmonary artery pressure \>/=60mm Hg), and/or dependent use of oxygen

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Alere San Diego: collaborator

Study Sites (2)

Lyndon B. Johnson General Hospital (LBJ)

Houston, Texas, 77026, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Narayan HK, Wei W, Feng Z, Lenihan D, Plappert T, Englefield V, Fisch M, Ky B. Cardiac mechanics and dysfunction with anthracyclines in the community: results from the PREDICT study. Open Heart. 2017 Jan 16;4(1):e000524. doi: 10.1136/openhrt-2016-000524. eCollection 2017.

  PMID: 28123764 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert A. Wolff, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2009
• First Posted: December 15, 2009
• Study Start: January 25, 2011
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (2)