Detection of Cancer in Breath Samples by Trained Detection Dogs
A Double-Blind Observational Study to Evaluate the Ability of Trained Detection Dogs to Detect Cancer in Breath Samples: The Rainbow Study
1 other identifier
observational
1,250
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2024
CompletedFirst Submitted
Initial submission to the registry
February 4, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedFebruary 12, 2024
January 1, 2024
2.9 years
February 4, 2024
February 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (7)
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
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
- +2 more secondary outcomes
Other Outcomes (4)
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
The duration for which a breath sample remains effective for detection by a detection dog
2 years
- +1 more other outcomes
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SpotitEarlylead
Study Sites (2)
Rambam Health Care Campus
Haifa, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Biospecimen
Breath samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadir Arber
Tel-Aviv Sourasky Medical Center
- PRINCIPAL INVESTIGATOR
Elizabeth Half
Rambam Health Care Campus
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2024
First Posted
February 12, 2024
Study Start
February 10, 2021
Primary Completion
January 22, 2024
Study Completion
March 1, 2024
Last Updated
February 12, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share