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. )

Study NCT00537199 Information provided by M.D. Anderson Cancer Center

First Received on September 26, 2007. Last Updated on December 11, 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. ]

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Serious Adverse Events

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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