Transcutaneous Breast Cancer Diagnosis by Canine Odorology

NCT ID: NCT04217109

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2023-04-25

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Odour sampling

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ANNE TARDIVON, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

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, , France

Countries

France

Other Identifiers

2019-A01592-55

Identifier Type: -

Identifier Source: org_study_id