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

Not Applicable

Completed

• Conditions: Surgery; Breast Cancer
• Interventions: Diagnostic Test: Sorbstar®; Diagnostic Test: Dog Detection

• Registration Number: NCT04541537
• 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).

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2021-01-25
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sorbstar®	Sorbstar®	Odour sampling : rub hands with Sorbstars® before and post-surgery
Dog Detection	Dog Detection	Odour sampling :sleep over a night with a compress on the affected breast before and after surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France