Malignant NeoplasmNCT00532064
Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
An observational study of Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Biospecimen Collection and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2007to 2 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MDACC Cancer Participants
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers
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).
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if specific biomarkers (troponin I and B-type natriuretic peptide [BNP]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (SU11248) or sorafenib chemotherapy.
SECONDARY OBJECTIVES:
- To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy.
OUTLINE:
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.
- Conditions
- Malignant Neoplasm
- Being tested
- Biospecimen Collection, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of each biomarker for detecting cardiotoxicity
Will estimate with exact 95% confidence intervals.
Measured: Up to 6 months
Specificity of each biomarker for detecting cardiotoxicity
Will estimate with exact 95% confidence intervals.
Measured: Up to 6 months
Secondary outcomes (2)
Incidence of cardiotoxicity
Will use the methods of Gooley, et al (1999) to estimate the cumulative incidence of cardiotoxicity while considering deaths from other causes as a competing risk. Will estimate the cumulative incidence of cardiotoxicity while stratifying by common risk factors (one at a time). Will use mixed linear models to model the biomarker levels over time, accounting for the correlation between biomarker levels within patient. Will use logistic regression to model the log odds of cardiotoxicity as a function of common risk factors for cardiotoxicity. Will also include the duration of chemotherapy use and the MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score as a potential prognostic factor for cardiotoxicity.
Measured: Up to 6 months
MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score
Will summarize the MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score over time with descriptive statistics and boxplots.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study start12 Sep 2007
- Primary completion2 May 2018
- Study completion2 May 2018
Why it stopped: Terminated per PI's request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elie Mouhayar, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532064
- Sponsor's protocol ID
- 2006-0921
- Other IDs
- NCI-2018-02471, 2006-0921, P30CA016672
- Status last verified
- Jan 2020
- First submitted
- 18 Sep 2007
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers
- ClinicalTrials.gov ID
- NCT00532064
- Acronym / sponsor ID
- 2006-0921
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated per PI's request
- Enrolment
- 55 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Sep 2007 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
PRIMARY OBJECTIVES:
- To determine if specific biomarkers (troponin I and B-type natriuretic peptide [BNP]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (SU11248) or sorafenib chemotherapy.
SECONDARY OBJECTIVES:
- To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy.
OUTLINE:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MDACC Cancer Participants
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood | Procedure or surgery | Ancillary-correlative (biospecimen collection) |
| Questionnaire AdministrationAncillary studies | Other | Ancillary-correlative (biospecimen collection) |
Primary outcome
Sensitivity of each biomarker for detecting cardiotoxicity
Time frame: Up to 6 months
Will estimate with exact 95% confidence intervals.
Specificity of each biomarker for detecting cardiotoxicity
Time frame: Up to 6 months
Will estimate with exact 95% confidence intervals.
2 secondary outcomes
Incidence of cardiotoxicity
Time frame: Up to 6 months
MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Terminated per PI's request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elie Mouhayar principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated per PI's request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of each biomarker for detecting cardiotoxicity (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.