CancerNCT00636844
Detection of Chemotherapy Induced Cardiotoxicity
An observational study of Cancer, run by George Washington University at 1 site in United States.
Trial summary
To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncology clinic patients
Who may be able to join
- undergoing anthracycline and/or trastuzumab therapy for the first time
Who cannot join
- abnormal ventricular ejection fraction
- past history of, or active cardiac disease including: MI, CHF, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20037
About this study
To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).
Read the detailed description
To identify patients at risk of development of heart damage after receiving chemotherapy by obtaining the genetic profile of those who show: elevation of troponin, left ventricular systolic and diastolic dysfunction, and pro-oxidant stress markers.
- Conditions
- Cancer
- Keywords
- chemotherapy, cardiotoxicity
- Medical subject headings
- Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time |
What is being measured
The primary outcome is the main question the study is designed to answer.
The genetic profile of patients with anthracycline-induced elevation of troponin-I
Measured: one year
Secondary outcomes (2)
Assess the genetic profile of patient with anthracycline-induced left ventricular systolic and diastolic dysfunction
Measured: one year
Assess the relationship of quantitative increases of pro-oxidant stress and a specific genetic profile
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jannet Lewis, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636844
- Sponsor's protocol ID
- JL-001
- Status last verified
- Aug 2012
- First submitted
- 10 Mar 2008
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Chemotherapy Induced Cardiotoxicity
- ClinicalTrials.gov ID
- NCT00636844
- Acronym / sponsor ID
- JL-001
- Conditions
- Cancer
- Keywords
- chemotherapy, cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Mar 2008 (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.
To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).
Detailed description
To identify patients at risk of development of heart damage after receiving chemotherapy by obtaining the genetic profile of those who show: elevation of troponin, left ventricular systolic and diastolic dysfunction, and pro-oxidant stress markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology clinic patients
Key inclusion criteria (1 listed)
- undergoing anthracycline and/or trastuzumab therapy for the first time
Key exclusion criteria (2 listed)
- abnormal ventricular ejection fraction
- past history of, or active cardiac disease including: MI, CHF, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The genetic profile of patients with anthracycline-induced elevation of troponin-I
Time frame: one year
2 secondary outcomes
Assess the genetic profile of patient with anthracycline-induced left ventricular systolic and diastolic dysfunction
Time frame: one year
Assess the relationship of quantitative increases of pro-oxidant stress and a specific genetic profile
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
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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.
Jannet Lewis, MD principal investigator
George Washington University
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 Cancer, run by George Washington University 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Mar 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The genetic profile of patients with anthracycline-induced elevation of troponin-I (time frame: one year). 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 13 Mar 2013.