Advanced CancerNCT01462383
The Role of the EKG in Anticancer Drug Development
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: -Evaluate incidence of cardiac complications in Phase I patients. Secondary Objective: -To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the detection of cardiac events. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- How many people
- 525 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of patients in the Department of Investigational Cancer Therapeutics diagnosed with a malignancy and registered at MDACC for medical care on IRB approved sponsored protocols active between January 1, 2006 and December 31, 2009.
Who may be able to join
- All types of advanced cancer
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the EKG in Anticancer Phase I Drug Development
Primary Objective:
-Evaluate incidence of cardiac complications in Phase I patients.
Secondary Objective:
-To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the detection of cardiac events.
Read the detailed description
The research plan includes a retrospective review of the chart of past UT MD Anderson Cancer Center (MDACC) patients and the experience in treating them.
All studies analyzed will be Phase I clinical trials.
Analysis is designed to collect information on the number of and timeframe within which ECGs are performed on these trials. Data on adverse events and serious adverse events, dose modifications based on ECG changes, attribution to drug, incidence and types of ECG changes specifically QTC prolongation as well as their influence on study procedures like dose limiting toxicities (DLTs) in dose escalation phase of the studies.
Study conducted using clinical records of patients treated on Phase I protocols in the MDACC Department of Investigational Cancer Therapeutics. The demographic data to be collected from patients whose charts will be analyzed will include variables such as age, gender, primary cancer, stage of the disease, performance status, treatment characteristics (i.e., number and type of prior therapies), disease status, adverse events, laboratory data (i.e., complete blood count/differential/platelets, tumor markers), and treatment outcomes.
The analysis will allow identification and descriptive analysis of the occurrence of cardiac events in the phase I population and will help define the role of protocol required EKGs in their detection.
HIPAA privacy and confidentiality guidelines will be followed. The database will be secured in the Department server. A Data coordinator has been recruited to undertake this project. The information derived from these observations will help the investigators formulate research questions and projects to develop future prospective studies.
The statistical analysis will be performed in a descriptive fashion with paired and multivariable analyses.
The analyses will be reported using summary tables, figures, and data listings. Continuous variables will be summarized using the mean, standard deviation, median, minimum, and maximum.
This study will be conducted at the MD Anderson Cancer Center in Houston, Texas.
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Malignancy, Cardiac complications, Electrocardiograms, ECG, Chart Review, Data Review, Data Analysis, Phase I, Clinical Research Study
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cardiac Complications in Participants on Phase I Protocols
Data review of studies, active between January 1, 2006 and December 31, 2009, who included ECGs in their safety evaluations. Use of identification and descriptive analysis of cardiac events occurrence in the phase I population to define role of protocol required EKGs in their detection. Statistical analysis performed in a descriptive fashion with paired and multivariable analyses.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Retrospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462383
- Sponsor's protocol ID
- DR11-0061
- Status last verified
- Dec 2011
- First submitted
- 27 Oct 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the EKG in Anticancer Phase I Drug Development
- ClinicalTrials.gov ID
- NCT01462383
- Acronym / sponsor ID
- DR11-0061
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Malignancy, Cardiac complications, Electrocardiograms, ECG, Chart Review, Data Review, Data Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Oct 2011 (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.
Primary Objective:
-Evaluate incidence of cardiac complications in Phase I patients.
Secondary Objective:
-To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the detection of cardiac events.
Detailed description
The research plan includes a retrospective review of the chart of past UT MD Anderson Cancer Center (MDACC) patients and the experience in treating them.
All studies analyzed will be Phase I clinical trials.
Analysis is designed to collect information on the number of and timeframe within which ECGs are performed on these trials. Data on adverse events and serious adverse events, dose modifications based on ECG changes, attribution to drug, incidence and types of ECG changes specifically QTC prolongation as well as their influence on study procedures like dose limiting toxicities (DLTs) in dose escalation phase of the studies.
Study conducted using clinical records of patients treated on Phase I protocols in the MDACC Department of Investigational Cancer Therapeutics. The demographic data to be collected from patients whose charts will be analyzed will include variables such as age, gender, primary cancer, stage of the disease, performance status, treatment characteristics (i.e., number and type of prior therapies), disease status, adverse events, laboratory data (i.e., complete blood count/differential/platelets, tumor markers), and treatment outcomes.
The analysis will allow identification and descriptive analysis of the occurrence of cardiac events in the phase I population and will help define the role of protocol required EKGs in their detection.
HIPAA privacy and confidentiality guidelines will be followed. The database will be secured in the Department server. A Data coordinator has been recruited to undertake this project. The information derived from these observations will help the investigators formulate research questions and projects to develop future prospective studies.
The statistical analysis will be performed in a descriptive fashion with paired and multivariable analyses.
The analyses will be reported using summary tables, figures, and data listings. Continuous variables will be summarized using the mean, standard deviation, median, minimum, and maximum.
This study will be conducted at the MD Anderson Cancer Center in Houston, Texas.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of patients in the Department of Investigational Cancer Therapeutics diagnosed with a malignancy and registered at MDACC for medical care on IRB approved sponsored protocols active between January 1, 2006 and December 31, 2009.
Key inclusion criteria (1 listed)
- All types of advanced cancer
Key exclusion criteria (1 listed)
- N/A
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
Incidence of Cardiac Complications in Participants on Phase I Protocols
Time frame: 3 years
Data review of studies, active between January 1, 2006 and December 31, 2009, who included ECGs in their safety evaluations. Use of identification and descriptive analysis of cardiac events occurrence in the phase I population to define role of protocol required EKGs in their detection. Statistical analysis performed in a descriptive fashion with paired and multivariable analyses.
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 12 Dec 2011.
- UT 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.
Aung Naing, MD principal investigator
UT MD 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 Advanced Cancer, 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 1 inclusion and 1 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 12 Dec 2011. 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?
Incidence of Cardiac Complications in Participants on Phase I Protocols (time frame: 3 years). 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 12 Dec 2011.