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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06255041

Enrollment

1386

Registered

2024-02-12

Start date

2021-02-10

Completion date

2024-01-31

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer, Lung Cancer, PROSTATE CANCER

Keywords

Breath Sample, Detection Dogs, Cancer Screening

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Men and women aged 18 and over. 2. Signing an informed consent prior to performing the test. 3. Intended to undergo screening tests for cancer detection. 4. Did not smoke 2 hours before providing the breath sample 5. Did not drink coffee in the hour before providing the breath sample 6. Did not drink an alcoholic beverage in the hour prior to providing the breath sample. 7. Did not eat food in the hour before providing the breath sample.

Exclusion criteria

1. 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. 2. Undergoing chemotherapy for any purpose. 3. Pregnant or breastfeeding 4. 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. 5. Has a Helicobacter pylori infection. 6. Has a peptic ulcer disease. 7. Has a flare-up of an inflammatory bowel disease (Crohn's disease/ulcerative colitis). 8. has an active infection, such as COVID-19, abscess, bacterial/viral/fungal infection, pneumonia, laryngitis, intestinal inflammation, active tuberculosis infection.

Design outcomes

Primary

Measure	Time frame	Description
Specificity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.	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.	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.

Secondary

Measure	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	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

Countries

Israel

Contacts

PRINCIPAL_INVESTIGATORNadir Arber

Tel-Aviv Sourasky Medical Center

PRINCIPAL_INVESTIGATORElizabeth Half

Rambam Health Care Campus

Outcome results