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OpenTrials
Completed

NCT Number: NCT04217109

Transcutaneous Breast Cancer Diagnosis by Canine Odorology

Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast ultrasound examination.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre République, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women 18 years and older, with one or more ipsilateral mammary lesion(s), palpable or not, detected at mammography and/or ultrasound and with at least one lesion classified as BI-RADS® category 4 or 5 with an indication of percutaneous sampling (cytology, microbiopsies, macro-biopsies) ;
  • Benefit from the national social security ;
  • Signature of the informed consent of the study ;
  • There is no contraindication for the person to simultaneously participate to another research program and there is no exclusion period planned after the study.

Exclusion criteria

  • Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
  • Patient with breast implant(s);
  • Patient with a personal history of breast surgery for benign lesion(s) of the concerned breast operated less than 4 weeks before the date of inclusion in this study;
  • Patient with a personal history of cancer (in situ or invasive) less than 5 years before inclusion whatever the anatomical site including cutaneous basal cell carcinoma;
  • Patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion;
  • Patient with a breast skin ulceration;
  • Patient under insulin (risk of sudation that may impair compress sample);
  • Concomitant antibiotics or corticoids taken one week before inclusion in the study;
  • Patient with a current viral infection (fever);
  • Persons under guardianship or deprived of liberty;
  • Impossibility to submit to the medical monitoring expected by the study for geographical or severe psychological reasons.

Treatment and study plan

Odour sampling

Diagnostic Test

Upon receipt of the samples at the Institute Curie-Paris, the compresses will be packed in jars and then transmitted to the dog center and analyzed by the study dogs.

Positive marking is characterized by a sitting position of the dog in front of the sample.

Primary outcomes

  1. Evaluate the sensitivity and specificity of canine odorology in women with breast lesion

    Time frame: 26 months

    The sensitivity and specificity of canine odorology in women with undeterminate breast lesion classified American College of Radiology (ACR) 4 or 5 (typically malignant) will be compared to the anatomopathological results of breast percutaneous sampling (biopsy)

Secondary outcomes

  1. Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)

    Time frame: 38 months

    Number of markings among compresses of patients affected and number of no-markings among compresses of patients not affected. The gold standard is the pathological examination of the operative specimen or the status of the patient at 1 year.

  2. Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology

    Time frame: 38 months

    Number of compresses of patient affected on number of markings (PPV) and number of compresses of patient non affected on number of no-markings (NPV) will be evaluated

  3. Patient compliance during the study

    Time frame: 26 months

    The rate of return of compresses after delivery of a kit will be evaluated

  4. Comparison between canine odorology and mammography

    Time frame: 38 months

    Comparison test of sensitivity and specificity values between canine odorology and mammography

  5. Performance of each dog

    Time frame: 26 months

    Sensitivity and specificity of canine odorology for each dog will be calculated

  6. Variability between dogs

    Time frame: 26 months

    A Cohen's kappa test will be used to explore the variability between trained dogs and dog breeds

  7. Performance of canine odorology if the test is based on 2 dogs

    Time frame: 24 months

    The results of the 2 dogs will be used to compare the performances

  8. Patient's satisfaction

    Time frame: 26 months

    A questionnaire will be completed by the patients to measure their satisfaction and indicate their level of agreement. A score from 0 (no anxiety) to 5 (very anxious) on a scale will be completed to assess anxiety, a score from 0 (very difficult) to 5 (very easy) will be used to ensure that the compress is easy to use.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology

Acronym: KDOG1

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2020
Registry last updated
Jul 14, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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