Transcutaneous Breast Cancer Diagnosis by Canine Odorology

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Odour sampling

• Registration Number: NCT04217109
• Lead Sponsor: Institut Curie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-03
• Study Start: 2020-02-03
• Status Verified: 2022-06
• Primary Completion: 2023-04-25
• Study Completion: 2023-04-25
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Odour sampling	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).

Primary Outcome Measures

Name	Time	Method
Evaluate the sensitivity and specificity of canine odorology in women with breast lesion	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 Outcome Measures

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

Trial Locations

Locations (6)

Centre Hospitalier Universitaire; 🇫🇷 Limoges, France

Centre Hospitalier Valenciennes; 🇫🇷 Valenciennes, France

Centre République; 🇫🇷 Clermont-Ferrand, France

Groupe Hospitalier Paris Saint- Joseph; 🇫🇷 Paris, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Nantes, France

Institut Curie; 🇫🇷 Saint-Cloud, France