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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Specificity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test. | 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. | 2 years |
| Sensitivity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test. | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 colorectal cancer |
| Measure | Description | Time Frame |
|---|---|---|
| The detection rate of types of cancer that the dog was not trained to detect | 2 years | |
| The rate of cancer detection among participants identified as negative by biopsy and positive by the breath test | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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Men and women over the age of 18 undergoing screening for early detection of breast cancer, colon cancer, lung cancer, and prostate cancer at the medical centers participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Nadir Arber | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Elizabeth Half | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | Israel | ||||
| Tel Aviv Sourasky Medical Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Breath samples
| 2 years |
| Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting lung cancer | 2 years |
| Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting prostate cancer | 2 years |
| The rate of early-stage cancer cases detected by the breath test | 2 years |
| Inter-observer variability among the detection dogs | 2 years |
| Intra-observer variability among the detection dogs | 2 years |
| The duration for which a breath sample remains effective for detection by a detection dog | 2 years |
| The duration for which a breath sample collected on an alternative mask substrate remains effective for detection by a detection dog | 2 years |
| Tel Aviv |
| Israel |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |