Breast CancerNCT06255041
Detection of Cancer in Breath Samples by Trained Detection Dogs
An observational study of Breast Cancer and Colorectal Cancer, run by SpotitEarly at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, PROSTATE CANCER
- How many people
- 1,386 participants
- Where
- 2 sitesIsrael
- Study dates
- 10 Feb 2021to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam Health Care Campus
Haifa
Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: A Double-Blind Observational Study to Evaluate the Ability of Trained Detection Dogs to Detect Cancer in Breath Samples: The Rainbow Study
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.
- Conditions
- Breast Cancer, Colorectal Cancer, PROSTATE CANCER, Lung Cancer
- Keywords
- Breath Sample, Detection Dogs, Cancer Screening
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (7)
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting breast cancer
Measured: 2 years
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting colorectal cancer
Measured: 2 years
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting lung cancer
Measured: 2 years
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting prostate cancer
Measured: 2 years
The rate of early-stage cancer cases detected by the breath test
Measured: 2 years
Inter-observer variability among the detection dogs
Measured: 2 years
Intra-observer variability among the detection dogs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start10 Feb 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,386 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpotitEarly
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadir Arber, Principal investigator, Tel-Aviv Sourasky Medical CenterElizabeth Half, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255041
- Sponsor's protocol ID
- SIE-001
- Status last verified
- Jun 2024
- First submitted
- 4 Feb 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Observational Study to Evaluate the Ability of Trained Detection Dogs to Detect Cancer in Breath Samples: The Rainbow Study
- ClinicalTrials.gov ID
- NCT06255041
- Acronym / sponsor ID
- SIE-001
- Conditions
- Breast Cancer, Colorectal Cancer, PROSTATE CANCER, Lung Cancer
- Keywords
- Breath Sample, Detection Dogs, Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,386 participants (actual)
- Lead sponsor
- SpotitEarlyIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specificity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.
Time frame: 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.
Sensitivity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.
Time frame: 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.
7 secondary outcomes
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting breast cancer
Time frame: 2 years
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting colorectal cancer
Time frame: 2 years
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting lung cancer
Time frame: 2 years
Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting prostate cancer
Time frame: 2 years
The rate of early-stage cancer cases detected by the breath test
Time frame: 2 years
Inter-observer variability among the detection dogs
Time frame: 2 years
Intra-observer variability among the detection dogs
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadir Arber principal investigator
Tel-Aviv Sourasky Medical Center
Elizabeth Half principal investigator
Rambam Health Care Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by SpotitEarly at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.