Study Stopped
Terminated per PI's request
Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers
3 other identifiers
observational
55
1 country
1
Brief Summary
This trial studies how well cardiac biomarkers work in the early detection of cardiotoxicity in patients receiving sunitinib malate or sorafenib chemotherapy. Some chemotherapies are known to cause damage to heart muscle cells, resulting in heart failure. Often, the damage is not detected until heart failure has already occurred. Testing for cardiac biomarkers, such as troponin I and/or T and B-type natriuretic peptide (BNP), may be useful in detecting heart damage earlier than other tests currently performed (such as echocardiogram and electrocardiogram).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2007
CompletedFirst Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2018
CompletedJanuary 22, 2020
January 1, 2020
10.6 years
September 18, 2007
January 17, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of each biomarker for detecting cardiotoxicity
Will estimate with exact 95% confidence intervals.
Up to 6 months
Specificity of each biomarker for detecting cardiotoxicity
Will estimate with exact 95% confidence intervals.
Up to 6 months
Secondary Outcomes (2)
Incidence of cardiotoxicity
Up to 6 months
MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score
Up to 6 months
Study Arms (1)
Ancillary-correlative (biospecimen collection)
Patients receive sunitinib malate or sorafenib chemotherapy then undergo blood collection 2 weeks later, and then every 4-6 weeks for up to 6 months to test for troponin I and BNP.
Interventions
Undergo collection of blood
Eligibility Criteria
MDACC Cancer Participants
You may qualify if:
- Patient age 18-85 years
- Starting a new course of chemotherapy at MD Anderson Cancer Center that includes sunitinib or sorafenib
- Has a life expectancy of greater than 6 months
You may not qualify if:
- Unstable angina within the last 3 months
- Myocardial infarction within the last 3 months
- Left ventricular ejection fraction (LVEF) less than 40%
- Decompensated heart failure (HF) in the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Elie Mouhayar
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2007
First Posted
September 19, 2007
Study Start
September 12, 2007
Primary Completion
May 2, 2018
Study Completion
May 2, 2018
Last Updated
January 22, 2020
Record last verified: 2020-01