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

Institut Curie

Status: Completed

Conditions: Breast Cancer; Surgery

Treatments: Diagnostic Test: Sorbstar®; Diagnostic Test: Dog Detection

Study type: Interventional

Funder types: Other

Identifiers

NCT04541537

IC 2020 08

Details and patient eligibility

About

To ascertain the possibilities to isolate the breast cancer olfactive signature

Full 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).

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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35 participants in 2 patient groups

Sorbstar®

Experimental group

Description:

Odour sampling : rub hands with Sorbstars® before and post-surgery

Treatment:

Diagnostic Test: Sorbstar®

Dog Detection

Experimental group

Description:

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

Treatment:

Diagnostic Test: Dog Detection