Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
- Conditions
- SurgeryBreast Cancer
- Interventions
- Diagnostic Test: Sorbstar®Diagnostic Test: Odour sampling
- Registration Number
- NCT03703557
- Lead Sponsor
- Institut Curie
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
- Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
- Of-Age female patient (over 18 years old)
- Life expectancy > to 1 year at the inclusion
- Performance status: 0 or 1 or 2
- Patient benefiting from the social security
- Signature informed consent of the study
- Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
- Wound presence on breasts
- Male subjects
- Specified metastatic breast cancer
- Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
- Persons under guardianship or deprived of liberty
- Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sorbstar® Sorbstar® Odour sampling: Rub hands with Sorbstar® before and post-surgery Dog detection Odour sampling Odour sampling: Sleep over a night with a compress on the affected breast before and after surgery
- Primary Outcome Measures
Name Time Method Ascertain breast cancer olfactive signature (Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®) 12 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 Outcome Measures
Name Time Method Ascertain breast cancer detection by the dogs of Curie Institut 13 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).
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®). 13 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.
Trial Locations
- Locations (1)
INSTITUT CURIE - Site de Saint Cloud
🇫🇷Saint-Cloud, France