Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Biosite
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01311843
First received: March 7, 2011
Last updated: June 7, 2013
Last verified: June 2013
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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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants, age 18-85 years, 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:
- Patient age 18-85 years
- 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
Exclusion Criteria:
- 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
- BNP >/= 200 pg/ml or troponin I >/= 0.4 ng/ml via use of the Biosite Triage Profiler Note: BNP and/or 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 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
Biosite
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: | June 7, 2013 |
| 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 June 17, 2013