OraTest in Combination With Visual Examination and Visual Examination Alone

Summary

Primary Objectives: 1. To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors. 2. To estimate the adjusted specificity of OraTest® in combination with visual examination in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity. Secondary Objectives: 1. To assess the ratio of sensitivity of OraTest® in combination with visual examination versus visual examination alone in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors. 2. To obtain the adjusted specificity of OraTest® in combination with visual examination in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity. 3. To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions. 4. To carry out gene expression studies on biopsies and map these onto an analysis of the widespread chromosomal imbalances in stain-positive and stain-negative lesions. 5. To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).

Timeline

Start

2006-11

Primary completion

2008-12

Completion

2008-12

Outcome

Outcome not reported

Stopped: “Study terminated early as per request by sponsor, Zila Biotechnology, Inc.”

Drugs

Indications