Prospective Clinical Study to Determine the Predictive Value of Sniffer Dogs to Identify Lung Cancer in the Exhalation of Patients With and Without Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
研究概览
简要总结
Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.
详细描述
All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
Three study groups are defined using the following inclusion and exclusion criteria:
- lung cancer: male & female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
- healthy individual: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
- chronic obstructive lung disease: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-80
- •competent
- •confirmed lung cancer
排除标准
- •history of other cancers
结局指标
主要结局
presence of an heretofore unknown substrate in the exhalation sample of a patient with confirmed lung cancer
时间窗: baseline
number of individuals in the study cohort with confirmed lung cancer whose exhalation sample is correctly identified by sniffer dogs to contain an heretofore unknown substrate that is associated with lung cancer
次要结局
- absence of an heretofore unknown substrate that is associated with lung cancer in patients with lung disease but excluded lung cancer(baseline)
研究者
Thorsten Walles
Principal Investigator
Schillerhoehe Hospital