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

Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

To ascertain the possibilities to isolate the breast cancer olfactive signature

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Surgery
• Intervention / Treatment: Diagnostic test: Sorbstar®; Diagnostic test: Dog Detection

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sorbstar®; Odour sampling : rub hands with Sorbstars® before and post-surgery	Diagnostic test: Sorbstar®; Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry
Experimental: Dog Detection; Odour sampling :sleep over a night with a compress on the affected breast before and after surgery	Diagnostic test: Dog Detection; Analysed by the dogs of Curie Institute at the training centers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To ascertain the possibilities to isolate the breast cancer olfactive signature	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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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®)	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.	18 months
Ascertain breast cancer detection by the dogs of Curie Institut	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).	18 months

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Fromantin Isabelle, PhD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IC 2020 08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No