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Trial Title:
Detection of Cancer in Breath Samples by Trained Detection Dogs
NCT ID:
NCT06255041
Condition:
Breast Cancer
Colorectal Cancer
PROSTATE CANCER
Lung Cancer
Conditions: Official terms:
Prostatic Neoplasms
Colorectal Neoplasms
Conditions: Keywords:
Breath Sample
Detection Dogs
Cancer Screening
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Rambam Health Care Campus
Address:
City:
Haifa
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Anastasia Weiss
Email:
A_WEIS@rambam.health.gov.il
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Lihi Argaman
Phone:
+972-3-697-3179
Email:
Lihibz@tlvmc.gov.il
Start date:
February 10, 2021
Completion date:
March 2024
Lead sponsor:
Agency:
SpotitEarly
Agency class:
Industry
Source:
SpotitEarly
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255041