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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06255041
Other study ID # SIE-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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