Clinical trial NCT03703557: Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
Official title: Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Surgery
Keywords: Breast
Volatile organic compounds
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Interventional, prospective, open, monocentric study with risks and minimal constraints
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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. 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. Specified metastatic breast cancer
5. Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
6. Persons under guardianship or deprived of liberty
7. Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.

Primary outcomes:
measure: Ascertain breast cancer olfactive signature (Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®)
timeFrame: 12 months
Secondary outcomes:
measure: 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®).
timeFrame: 13 months
measure: Ascertain breast cancer detection by the dogs of Curie Institut
timeFrame: 13 months
Other outcomes:
Locations:
city: Saint-Cloud
country: France
facility: INSTITUT CURIE - Site de Saint Cloud
Study officials:
affiliation: Institut Curie
name: Roman ROUZIER, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Curie
name: Isabelle FROMANTIN, Phd, IDE
role: STUDY_DIRECTOR
References: