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NCT Number: NCT06255041

Detection of Cancer in Breath Samples by Trained Detection Dogs

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Health Care Campus, Haifa, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Specificity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.

    Time frame: 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.

  2. Sensitivity of detection of any cancer (breast, lung, prostate or colorectal cancer) by the breath test.

    Time frame: 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 outcomes

  1. Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting breast cancer

    Time frame: 2 years

  2. Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting colorectal cancer

    Time frame: 2 years

  3. Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting lung cancer

    Time frame: 2 years

  4. Specificity, sensitivity, negative predictive value, and positive predictive value of the breath test for detecting prostate cancer

    Time frame: 2 years

  5. The rate of early-stage cancer cases detected by the breath test

    Time frame: 2 years

  6. Inter-observer variability among the detection dogs

    Time frame: 2 years

  7. Intra-observer variability among the detection dogs

    Time frame: 2 years

Other outcomes

  1. The detection rate of types of cancer that the dog was not trained to detect

    Time frame: 2 years

  2. The rate of cancer detection among participants identified as negative by biopsy and positive by the breath test

    Time frame: 2 years

  3. The duration for which a breath sample remains effective for detection by a detection dog

    Time frame: 2 years

  4. The duration for which a breath sample collected on an alternative mask substrate remains effective for detection by a detection dog

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

SpotitEarly

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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