OraTest in Combination With Visual Examination and Visual Examination Alone
Condition: Head And Neck Cancer; Oropharynx Cancer
MeSH terms: Oropharyngeal Neoplasms
Intervention: Visual Examination; OraTest
Intervention description: Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.; Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Head And Neck; Oropharynx; Oral Cancer; OraTest; OraTest Dye; Rinse Staining Procedure; Visual Examination

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®).
    

Eligibility criteria:

        Inclusion Criteria:

          1. High risk of oral cancer as defined by a twenty-pack/year cigarette smoking history or
             equivalent and is either a current smoker or has quit smoking within the last 24
             months. Twenty-pack/year equivalent is defined as ½ pack/day for 40 years, or one
             pack/day for 20 years, or 2 packs/day for 10 years, or 4 packs/day for 5 years.
             AND/OR;

          2. Ten-year history of twenty orally-consumed alcohol units/week and is either a current
             drinker or has quit drinking within the last 24 months. Twenty orally-consumed alcohol
             units/week is defined as the equivalent of twenty - 1 ounce shots of whisky or
             spirits/week (20 ounces = 600 mL), or twenty - 3 ounce glasses of wine/week (60 ounces
             = 1800 mL), or twenty - 12 ounce glasses of beer/week (240 ounces = 7200 mL);

          3. Male or female, at least 45 years of age;

          4. Written informed consent.

          5. Females of childbearing potential may be enrolled following a negative urine pregnancy
             test performed at the SE visit. Abstinence will be considered an acceptable form of
             birth control.

        Exclusion Criteria:

          1. History of oral cancer, surgery or biopsy for suspected oral neoplasm;

          2. History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or
             current orthodonture (e.g., braces);

          3. Known hypersensitivity to study drug or its analogs;

          4. Active and uncontrolled infection or any other severe concurrent disease that in the
             judgment of the investigator would make the patient inappropriate for entry into this
             study;

          5. Psychiatric disorders which would interfere with informed consent or follow-up;

          6. Use of any investigational agent within previous 30 days;

          7. Female that is lactating or demonstrating positive pregnancy test;

          8. Patients in whom betel nut use/abuse has been reported within the past 5 years;

          9. Patients currently taking medication containing prohibited dyes.