Transcutaneous Breast Cancer Diagnosis by Canine Odorology (KDOG1)

KDOG1 :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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Odour sampling

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Centre République
  • Limoges, France, 87000
    • Centre Hospitalier Universitaire
  • Nantes, France, 44
    • Institut de Cancérologie de l'Ouest
  • Paris, France, 75
    • Groupe Hospitalier Paris Saint- Joseph
  • Paris, France, 75
    • Institut Curie
  • Saint-Cloud, France, 92
    • Institut Curie
  • Valenciennes, France, 59
    • Centre Hospitalier Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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) ;
2. Benefit from the national social security ;
3. Signature of the informed consent of the study ;
4. 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:

1. Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
2. Patient with breast implant(s);
3. 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;
4. 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;
5. Patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion;
6. Patient with a breast skin ulceration;
7. Patient under insulin (risk of sudation that may impair compress sample);
8. Concomitant antibiotics or corticoids taken one week before inclusion in the study;
9. Patient with a current viral infection (fever);
10. Persons under guardianship or deprived of liberty;
11. Impossibility to submit to the medical monitoring expected by the study for geographical or severe psychological reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Odour sampling; Odour collection will be obtained by positioning a compress on the breast concerned during the night preceding the day of samplings. The compress, once removed, will be placed in specific envelope for the study. Envelope will be given to the investigating centre during the appointment of percutaneous samples and then sent to the sponsor center (Institute Curie Paris).

Diagnostic test: Odour sampling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the sensitivity and specificity of canine odorology in women with breast lesion	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)	26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)	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.	38 months
Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology	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	38 months
Patient compliance during the study	The rate of return of compresses after delivery of a kit will be evaluated	26 months
Comparison between canine odorology and mammography	Comparison test of sensitivity and specificity values between canine odorology and mammography	38 months
Performance of each dog	Sensitivity and specificity of canine odorology for each dog will be calculated	26 months
Variability between dogs	A Cohen's kappa test will be used to explore the variability between trained dogs and dog breeds	26 months
Performance of canine odorology if the test is based on 2 dogs	The results of the 2 dogs will be used to compare the performances	24 months
Patient's satisfaction	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.	26 months

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: ANNE TARDIVON, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; Dog Detection; Volatile organic Compounds
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2019-A01592-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No