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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Odour sampling | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odour sampling | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ANNE TARDIVON, MD | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre République | Clermont-Ferrand | 63000 | France | |||
| Centre Hospitalier Universitaire |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 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 |
| Limoges |
| 87000 |
| France |
| Institut de Cancérologie de l'Ouest | Nantes | 44 | France |
| Groupe Hospitalier Paris Saint- Joseph | Paris | 75 | France |
| Institut Curie | Paris | 75 | France |
| Institut Curie | Saint-Cloud | 92 | France |
| Centre Hospitalier Valenciennes | Valenciennes | 59 | France |
| D017437 |
| Skin and Connective Tissue Diseases |