Breast Cancer, Surgery
Conditions
Brief summary
To ascertain the possibilities to isolate the breast cancer olfactive signature
Detailed description
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).
Interventions
DIAGNOSTIC_TESTSorbstar®
Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry
DIAGNOSTIC_TESTDog Detection
Analysed by the dogs of Curie Institute at the training centers
Sponsors
Institut Curie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Experimental, interventional, prospective, open, monocentric study with risks and minimal constraints
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection 2. Of-Age female patient (over 18 years old) 3. Life expectancy \> to 1 year at the inclusion 4. ECOG performance status: 0 or 1 or 2 5. Patient benefiting from the social security 6. Signature informed consent of the study
Exclusion criteria
1. Neoplasia in progress or neoplasia history of cancer other than breast to be treated. 2. Wound presence on breasts 3. Male subjects 4. Pregnant or lactating women 5. Specified metastatic breast cancer 6. Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics) 7. Persons under guardianship or deprived of liberty 8. Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To ascertain the possibilities to isolate the breast cancer olfactive signature | 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ascertain breast cancer olfactive signature from the tumor (Isolation of volatile Organic Compounds to tumor breast samples by a sensitive technique with an odor-sensing polymer (Sorbstar®) | 18 months | 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. |
| Ascertain breast cancer detection by the dogs of Curie Institut | 18 months | 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). |
Countries
France
Outcome results
None listed