Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Specificity
研究概览
简要总结
A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.
详细描述
This is a prospective, multi-center study. Subjects with OSCC or OPSCC will be enrolled from four primary and secondary care centers in the U.S. Study samples will be collected by the clinicians at the study sites using Viome saliva sample collection kits. Patients will continue with their current health plan and confirm diagnosis following the standard of care of surgical biopsy with histology if needed. If a biopsy is performed, the result of the biopsy will be compared with the result of the Viome kit. If no biopsy is performed, the Viome test result will be compared with the physician's assessment based on clinical judgment. Patients with a positive result from histology will not receive the results of the Viome kit, and it will not play any part in the clinical management of the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent prior to any study-specific procedures are performed
- •Willing and able to follow the study instructions, as described in the recruitment letter
- •Adults (18 years old or older)
- •Suspicion of OSCC or OPSCC on clinical presentation by a clinician
排除标准
- •Pregnancy
- •Use of fertility enhancing medications
结局指标
主要结局
Specificity
时间窗: Through study completion, an average of 18 months
Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative
Sensitivity
时间窗: Through study completion, an average of 18 months
Oral/Throat cancer test's ability to designate an individual with disease as positive
Negative Post Test Probability (NPV)
时间窗: Through study completion, an average of 18 months
The probability of having the target condition if the test falls out negative
Positive Post Test Probability (PPV)
时间窗: Through study completion, an average of 18 months
The probability of having the target condition if the test falls out positive
次要结局
- Sensitivity by disease stage (I, II, III, and IV)(Through study completion, an average of 18 months)
- Sensitivity by age(Through study completion, an average of 18 months)
- Sensitivity by recurrent cancer(Through study completion, an average of 18 months)
- Specificity by care center (primary and secondary)(Through study completion, an average of 18 months)
- Sensitivity by sex(Through study completion, an average of 18 months)
- Sensitivity by oral cancer type (OSCC or OPSCC)(Through study completion, an average of 18 months)
- Specificity by age(Through study completion, an average of 18 months)
- Specificity by oral cancer type (OSCC or OPSCC)(Through study completion, an average of 18 months)
- Specificity by disease stage (I, II, III, and IV)(Through study completion, an average of 18 months)
- Specificity by recurrent cancer(Through study completion, an average of 18 months)
- Sensitivity by care center (primary and secondary)(Through study completion, an average of 18 months)
- Sensitivity by metastasis(Through study completion, an average of 18 months)
- Specificity by smoking history(Through study completion, an average of 18 months)
- Specificity by metastasis(Through study completion, an average of 18 months)
- Sensitivity by race(Through study completion, an average of 18 months)
- Sensitivity by smoking history(Through study completion, an average of 18 months)
- Sensitivity by HPV status(Through study completion, an average of 18 months)
- Specificity by sex(Through study completion, an average of 18 months)
- Specificity by race(Through study completion, an average of 18 months)
- Specificity by HPV status(Through study completion, an average of 18 months)