Transcutaneous Breast Cancer Diagnosis by Canine Odorology (KDOG1)

Institut Curie

Status: Completed

Conditions: Breast Cancer

Treatments: Diagnostic Test: Odour sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04217109

2019-A01592-55

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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196 participants in 1 patient group

Odour sampling

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Odour sampling