Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
试验速览
- 阶段
- 不适用
- 入组人数
- 485
- 试验地点
- 16
- 主要终点
- First step: Confirm that the parameters used for the development of the test to qualify it as positive or negative lead to the same level of sensitivity (98%)
研究概览
简要总结
This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months.
If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First step:
- •Man or woman aged more than 40 years
- •With frequent alcohol intoxication and/or smoking
- •With histologically confirmed epidermoid carcinoma of the upper aerodigestive tract
- •No treatment delivered for this disease
- •Signed, written informed consent
- •Mandatory affiliation with a health insurance system
- •Second step:
- •Man or woman aged more than 40 years
- •With frequent alcohol intoxication and/or smoking
- •With no sign of an epidermoid carcinoma of the upper aerodigestive tract
- •Signed, written informed consent
- •Mandatory affiliation with a health insurance system
排除标准
- •First step:
- •Previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent
- •Gingivorrhagia when the test is realised
- •Hypersensitivity to aspirin or to benzoate
- •Asthmatic, diabetic patients or patents with chronic bronchitis requiring oxygen therapy
- •Patients taking antibiotics at enrolment or during the previous week
- •Second step:
- •Previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent
- •Patient already treated for a cancer
- •Gingivorrhagia when the test is realised
- •Hypersensitivity to aspirin or to benzoate
- •Asthmatic, diabetic patients or patients with chronic bronchitis requiring oxygen therapy
- •Patients on antibiotics at enrolment or during the previous week
结局指标
主要结局
First step: Confirm that the parameters used for the development of the test to qualify it as positive or negative lead to the same level of sensitivity (98%)
时间窗: 1 year after the beginning of enrollment
The algorithm was first defined when the test was developed in patients on different tumour stages .
Second step: Determine the characteristics of the Oncoral® test
时间窗: 2 years after the beginning of the second step enrolment
Sensitivity, specificity, positive predictive value, negative predictive value.
次要结局
- First step: Estimation of test sensitivity(1 year after the beginning of enrolment)
- Second step : Estimation of test feasibility(2 years after the beginning of the second step enrolment)
- Second step: Estimation of the prevalence of epidermoid carcinoma of the upper aerodigestive tract in the target population(3 years after the beginning of the second step enrolment)