Clinical trial NCT04217109: Transcutaneous Breast Cancer Diagnosis by Canine Odorology
Official title: KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Dog Detection
Volatile organic Compounds
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the sensitivity and specificity of canine odorology in women with breast lesion
timeFrame: 26 months
Secondary outcomes:
measure: Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)
timeFrame: 38 months
measure: Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology
timeFrame: 38 months
measure: Patient compliance during the study
timeFrame: 26 months
measure: Comparison between canine odorology and mammography
timeFrame: 38 months
measure: Performance of each dog
timeFrame: 26 months
measure: Variability between dogs
timeFrame: 26 months
measure: Performance of canine odorology if the test is based on 2 dogs
timeFrame: 24 months
measure: Patient's satisfaction
timeFrame: 26 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre République
city: Limoges
country: France
facility: Centre Hospitalier Universitaire
city: Nantes
country: France
facility: Institut de Cancérologie de l'Ouest
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint- Joseph
city: Paris
country: France
facility: Institut Curie
city: Saint-Cloud
country: France
facility: Institut Curie
city: Valenciennes
country: France
facility: Centre Hospitalier Valenciennes
Study officials:
affiliation: Institut Curie
name: ANNE TARDIVON, MD
role: PRINCIPAL_INVESTIGATOR
References: