Transcutaneous Breast Cancer Diagnosis by Canine Odorology

Breast Cancer Clinical Trial

— KDOG1  

Official title:

KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217109
• Other study ID #: 2019-A01592-55
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: April 25, 2023

Study information

• Verified date: June 2022
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Centre République	Clermont-Ferrand
France	Centre Hospitalier Universitaire	Limoges
France	Institut de Cancérologie de l'Ouest	Nantes
France	Groupe Hospitalier Paris Saint- Joseph	Paris
France	Institut Curie	Paris
France	Institut Curie	Saint-Cloud
France	Centre Hospitalier Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient compliance during the study	The rate of return of compresses after delivery of a kit will be evaluated	26 months
Secondary	Comparison between canine odorology and mammography	Comparison test of sensitivity and specificity values between canine odorology and mammography	38 months
Secondary	Performance of each dog	Sensitivity and specificity of canine odorology for each dog will be calculated	26 months
Secondary	Variability between dogs	A Cohen's kappa test will be used to explore the variability between trained dogs and dog breeds	26 months
Secondary	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
Secondary	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