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OraTest in Combination With Visual Examination and Visual Examination Alone

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ClinicalTrials.gov Identifier: NCT00537199
Recruitment Status : Terminated (Study terminated early as per request by sponsor, Zila Biotechnology, Inc.)
First Posted : September 28, 2007
Results First Posted : January 18, 2010
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Zila Biotechnology, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head And Neck Cancer
Oropharynx Cancer
Interventions Other: Visual Examination
Drug: OraTest
Enrollment 1
Recruitment Details 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 Only 1 patient enrolled prior to sponsor Zila Biotechnology terminating study. Study monitoring done by sponsor; no final data available on part of University of Texas (UT) MD Anderson Cancer Center.
Arm/Group Title OraTest + Visual Exam
Hide Arm/Group Description Visual oral exam, followed by OraTest Rinse Staining Procedure
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Study Terminated             1
Arm/Group Title OraTest + Visual Exam
Hide Arm/Group Description Visual oral exam, followed by OraTest Rinse Staining Procedure
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
64
(64 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone
Hide Description

Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.

Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.

Time Frame Following two (2) scheduled visits for visual examination, up to one month following first exam
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed. Study was terminated by sponsor.
Arm/Group Title OraTest + Visual Exam
Hide Arm/Group Description:
Visual oral exam, followed by OraTest Rinse Staining Procedure
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event collection from first exam to confirmation exam two weeks later, followed up to one month.
Adverse Event Reporting Description Study was terminated after first patient enrolled.
 
Arm/Group Title OraTest + Visual Exam
Hide Arm/Group Description Visual oral exam, followed by OraTest Rinse Staining Procedure
All-Cause Mortality
OraTest + Visual Exam
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OraTest + Visual Exam
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OraTest + Visual Exam
Affected / at Risk (%)
Total   0/1 (0.00%) 
Early termination by sponsor resulted in only 1 patient enrolled and no analysis.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Chambers, MS, DMD / Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-792-6510
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00537199     History of Changes
Other Study ID Numbers: 2005-1008
First Submitted: September 26, 2007
First Posted: September 28, 2007
Results First Submitted: December 11, 2009
Results First Posted: January 18, 2010
Last Update Posted: May 13, 2016