A Double-Blind Observational Study to Evaluate the Ability of Trained Detection Dogs to Detect Cancer in Breath Samples: The Rainbow Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,386
- 试验地点
- 4
- 主要终点
- Sensitivity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.
研究概览
简要总结
The goal of this study is to show that trained detection dogs can identify breast, lung, prostate or colorectal cancer by sniffing masks containing breath samples. In this study, individuals who will undergo cancer screening at an integrated cancer prevention center or biopsy for a suspected malignancy, will be asked to provide a breath sample by breathing into a surgical mask. The mask will then be sent to the laboratory, where trained detection dogs will determine if the person who provided the mask has breast, lung, prostate or colorectal cancer or if the person does not have these types of cancer. The results provided by the dogs will be compared to the actual cancer screening results or biopsy results in order to determine the accuracy of cancer detection by the trained dogs.
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
- 是
入选标准
- •Men and women aged 18 and over.
- •Signing an informed consent prior to performing the test.
- •Intended to undergo screening tests for cancer detection.
- •Did not smoke 2 hours before providing the breath sample
- •Did not drink coffee in the hour before providing the breath sample
- •Did not drink an alcoholic beverage in the hour prior to providing the breath sample.
- •Did not eat food in the hour before providing the breath sample.
排除标准
- •Was diagnosed with cancer or was treated for cancer in the seven years preceding the study, excluding non-metastatic skin tumors that were surgically removed.
- •Undergoing chemotherapy for any purpose.
- •Pregnant or breastfeeding
- •Had a medical procedure in the chest cavity and/or airways in the two weeks prior to providing the breath sample that may interfere with the ability to correctly provide a breath sample.
- •Has a Helicobacter pylori infection.
- •Has a peptic ulcer disease.
- •Has a flare-up of an inflammatory bowel disease (Crohn's disease/ulcerative colitis).
- •has an active infection, such as COVID-19, abscess, bacterial/viral/fungal infection, pneumonia, laryngitis, intestinal inflammation, active tuberculosis infection.
结局指标
主要结局
Sensitivity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.
时间窗: 2 years
Sensitivity is defined as the number of participants who were identified by the breath sample test as positive for cancer divided by the number of participants who were identified by the gold standard test as being positive for cancer.
Specificity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.
时间窗: 2 years
Specificity is defined as the number of participants who were identified by the breath sample test as negative for cancer divided by the number of participants who were identified by the gold standard test as being negative for cancer.
次要结局
- Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting colorectal cancer(2 years)
- The rate of early-stage cancer cases detected by the breath test(2 years)
- Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting breast cancer(2 years)
- Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting prostate cancer(2 years)
- Inter-observer variability among the detection dogs(2 years)
- Intra-observer variability among the detection dogs(2 years)
- Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting lung cancer(2 years)