Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Odour sampling: Rub hands with Sorbstar® before and post-surgery

Odour sampling: Sleep over a night with a compress on the affected breast before and after surgery

Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.

Sorbstar®

Analyzed by the dogs of Curie Institute at the training centers

Odour sampling

Roman ROUZIER, Phd

Isabelle FROMANTIN, Phd, IDE

To ascertain the possibilities to isolate the breast cancer olfactive signature.

Patient recruitment during the first surgery consultation in Curie Institute. Odor sampling (non-invasive) with an odor-sensing polymer (Sorbstar® polymer developed especially for the trace level analysis), on:

* The hands, before and after surgical excision of the tumor (friction of the hands)
* The diseased breast, before and after surgical excision of the tumor (via a compress positioned on the breast for 1 night)
* The tumor, during the surgical procedure (odor collection over a tumor sample).

Each patient will be her own witness, before and after surgical excision, in an attempt to isolate the chemical signature tracks of breast cancer. The samples after surgery will be made after healing and before implementation of a treatment (chemotherapy and / or radiotherapy).

Interventional, prospective, open, monocentric study with risks and minimal constraints

Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®) on hands. Friction of the hands according to the protocol before and after surgical excision of the tumor. Sorbstar® analyses will be performed with a thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.

During the surgical procedure an odor-sensing polymer (Sorbstar®) over the tumor is placed. Sorbstar® analyzes will be performed with a thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.

Patients sleep over a night with a compress positioned on the affected breast before and after surgery. The compress will be analyzed by the dogs of Curie Institut (results cancer/not cancer).

Institut Curie

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).

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.

ANNE TARDIVON, MD

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.

Transcutaneous Breast Cancer Diagnosis by Canine Odorology

KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology

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)

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.

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

The rate of return of compresses after delivery of a kit will be evaluated

Comparison test of sensitivity and specificity values between canine odorology and mammography

Sensitivity and specificity of canine odorology for each dog will be calculated

A Cohen's kappa test will be used to explore the variability between trained dogs and dog breeds

The results of the 2 dogs will be used to compare the performances

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer	NCT03703557	Breast Cancer Surgery	Sorbstar® Odour sampling	18 Years -	Institut Curie
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer	NCT03703557	Breast Cancer Surgery	Sorbstar® Odour sampling	18 Years -	Institut Curie
Transcutaneous Breast Cancer Diagnosis by Canine Odorology	NCT04217109	Breast Cancer	Odour sampling	18 Years -	Institut Curie

Spots Global Cancer Trial Database for odour sampling