Detection of Cancer in Breath Samples by Trained Detection Dogs

Breast Cancer Clinical Trial

Official title:

A Double-Blind Observational Study to Evaluate the Ability of Trained Detection Dogs to Detect Cancer in Breath Samples: The Rainbow Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255041
• Other study ID #: SIE-001
• Status: Recruiting
• Start date: February 10, 2021
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: SpotitEarly
• Contact: Udi Bobrovsky
• Phone: +972-54-456-0008
• Email: udi[@]spotitearly.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: March 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• PROSTATE CANCER

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
SpotitEarly

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The detection rate of types of cancer that the dog was not trained to detect		2 years
Other	The rate of cancer detection among participants identified as negative by biopsy and positive by the breath test		2 years
Other	The duration for which a breath sample remains effective for detection by a detection dog		2 years
Other	The duration for which a breath sample collected on an alternative mask substrate remains effective for detection by a detection dog		2 years
Primary	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
Primary	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	Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting breast cancer		2 years
Secondary	Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting colorectal cancer		2 years
Secondary	Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting lung cancer		2 years
Secondary	Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting prostate cancer		2 years
Secondary	The rate of early-stage cancer cases detected by the breath test		2 years
Secondary	Inter-observer variability among the detection dogs		2 years
Secondary	Intra-observer variability among the detection dogs		2 years