Clinical trial NCT06255041: Detection of Cancer in Breath Samples by Trained Detection Dogs
Official title: A Double-Blind Observational Study to Evaluate the Ability of Trained Detection Dogs to Detect Cancer in Breath Samples: The Rainbow Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Colorectal Cancer
PROSTATE CANCER
Lung Cancer
Keywords: Breath Sample
Detection Dogs
Cancer Screening
Lead sponsor: SpotitEarly
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Specificity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.
timeFrame: 2 years
measure: Sensitivity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.
timeFrame: 2 years
Secondary outcomes:
measure: Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting breast cancer
timeFrame: 2 years
measure: Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting colorectal cancer
timeFrame: 2 years
measure: Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting lung cancer
timeFrame: 2 years
measure: Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting prostate cancer
timeFrame: 2 years
measure: The rate of early-stage cancer cases detected by the breath test
timeFrame: 2 years
measure: Inter-observer variability among the detection dogs
timeFrame: 2 years
measure: Intra-observer variability among the detection dogs
timeFrame: 2 years
Other outcomes:
measure: The detection rate of types of cancer that the dog was not trained to detect
timeFrame: 2 years
measure: The rate of cancer detection among participants identified as negative by biopsy and positive by the breath test
timeFrame: 2 years
measure: The duration for which a breath sample remains effective for detection by a detection dog
timeFrame: 2 years
measure: The duration for which a breath sample collected on an alternative mask substrate remains effective for detection by a detection dog
timeFrame: 2 years
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nadir Arber
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Elizabeth Half
role: PRINCIPAL_INVESTIGATOR
References: