The Role of the EKG in Anticancer Drug Development
1 other identifier
observational
525
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Shorter than P25 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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 27, 2011
CompletedFirst Posted
Study publicly available on registry
October 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 12, 2011
December 1, 2011
10 months
October 27, 2011
December 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years
Eligibility Criteria
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.
You may qualify if:
- All types of advanced cancer
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Aung Naing, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2011
First Posted
October 31, 2011
Study Start
January 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 12, 2011
Record last verified: 2011-12