Evaluation of OraTest in Combination With Visual Examination in the Improved Detection of Oral Mucosal Lesions Suspicious of Serious Pathology in High-Risk Patients for the Purpose of Referral to the Health Care Professional Experienced in Oral Cancer: Phase III Clinical Trial Comparing the Sensitivity and Assessing the Specificity of OraTest in Combination With Visual Examination and Visual Examination Alone in Patients at High Risk as Defined by Age and Lifestyle Factors (ZIL-401)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone
研究概览
简要总结
Primary Objectives:
- 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.
- 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:
- 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.
- 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.
- To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions.
- 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.
- To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).
详细描述
OraTest® is a blue dye that is designed to stain cancer cells differently than normal cells.
SCHEDULED EVALUATION (FIRST VISIT):
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your medical history will be recorded. Women who are able to have children must have a negative urine pregnancy test. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the first visit.
Visual Exam - If you are found to be eligible to take part in this study, you will have a visual examination where a doctor (Examiner #1) will look inside your mouth very carefully to look for any abnormal lesions and check the glands in your neck. This is called the visual exam.
Rinse Staining Procedure (OraTest®) - A second doctor (Examiner #2) will perform another oral exam, followed by the new test using OraTest®. This new test uses a blue dye which may stain any potential cancer blue so it may make it easier for the doctor to detect any abnormal lesions in your mouth. You will be asked not to have intensely-colored sweets like lollipops or drinks like black currant juice within 24 hours of your scheduled visit. First you will rinse your mouth with about 6 teaspoons of vinegar solution for about 20 seconds and spit it out. Next you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Then you will rinse your mouth with about 2 teaspoons of OraTest® for 20 seconds and spit it out. Then you will rinse your mouth with about 6 teaspoons of vinegar solution for 20 seconds and then spit it out. Then you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Examiner 2 will then check and see if any abnormal tissue absorbed the dye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
- •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);
- •Male or female, at least 45 years of age;
- •Written informed consent.
- •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.
排除标准
- •History of oral cancer, surgery or biopsy for suspected oral neoplasm;
- •History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or current orthodonture (e.g., braces);
- •Known hypersensitivity to study drug or its analogs;
- •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;
- •Psychiatric disorders which would interfere with informed consent or follow-up;
- •Use of any investigational agent within previous 30 days;
- •Female that is lactating or demonstrating positive pregnancy test;
- •Patients in whom betel nut use/abuse has been reported within the past 5 years;
- •Patients currently taking medication containing prohibited dyes.
研究组 & 干预措施
OraTest + Visual Exam
OraTest dye
干预措施: Visual Examination (Other)
OraTest + Visual Exam
OraTest dye
干预措施: OraTest (Drug)
结局指标
主要结局
Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone
时间窗: Following two (2) scheduled visits for visual examination, up to one month following first exam
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.
次要结局
未报告次要终点