The Role of the EKG in Anticancer Drug Development
-Evaluate incidence of cardiac complications in Phase I patients.
-To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the detection of cardiac events.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||The Role of the EKG in Anticancer Phase I Drug Development|
- Incidence of Cardiac Complications in Participants on Phase I Protocols [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462383
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||UT MD Anderson Cancer Center|