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OraTest in Combination With Visual Examination and Visual Examination Alone

This study has been terminated.
(Study terminated early as per request by sponsor, Zila Biotechnology, Inc.)
Sponsor:
Collaborator:
Zila Biotechnology
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00537199
First received: September 26, 2007
Last updated: December 11, 2009
Last verified: December 2009
History of Changes
Results First Received: December 11, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Oropharynx Cancer
Interventions: Other: Visual Examination
Drug: OraTest

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 06/04/07 through 06/22/07. Single participant recruited at UT MD Anderson Cancer Center although multi-center study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only 1 patient enrolled prior to sponsor Zila Biotechnology terminating study. Study monitoring done by sponsor; no final data available on part of UT MD Anderson Cancer Center.

Reporting Groups
  Description
OraTest + Visual Exam OraTest dye

Participant Flow:   Overall Study
    OraTest + Visual Exam  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Study Terminated                 1  



  Baseline Characteristics
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Reporting Groups
  Description
OraTest + Visual Exam OraTest dye

Baseline Measures
    OraTest + Visual Exam  
Number of Participants  
[units: participants]
 		  1  
Age  
[units: years]
Median ( Full Range ) 		  64  
  ( 64 to 64 )  
Gender  
[units: participants]
 		 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 		 
United States     1  



  Outcome Measures

1.  Primary:   Ratio of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone   [ Time Frame: Two (2) scheduled visits for visual examination. ]
  Show Outcome Measure 1


  Serious Adverse Events
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Time Frame One month
Additional Description Study was terminated after first patient enrolled.

Reporting Groups
  Description
OraTest + Visual Exam OraTest dye

Serious Adverse Events
    OraTest + Visual Exam  
Total, serious adverse events    
# participants affected / at risk     0/0 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination by sponsor resulted in only 1 patient enrolled and no analysis.  


Results Point of Contact:  
Name/Title: Mark Chambers, MS, DMD / Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-6510


No publications provided


Responsible Party: Mark S. Chambers, MD / Professor, U.T. M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00537199     History of Changes
Other Study ID Numbers: 2005-1008
Study First Received: September 26, 2007
Results First Received: December 11, 2009
Last Updated: December 11, 2009
Health Authority: United States: Food and Drug Administration