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

• Sponsor: Institut Curie (Other)
• Overall Status: Completed
• CT.gov ID: NCT04541537
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

To ascertain the possibilities to isolate the breast cancer olfactive signature

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Surgery	Diagnostic Test: Sorbstar®; Diagnostic Test: Dog Detection	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Experimental, interventional, prospective, open, monocentric study with risks and minimal constraintsExperimental, interventional, prospective, open, monocentric study with risks and minimal constraints
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
• Actual Study Start Date: Jan 25, 2021
• Actual Primary Completion Date: Dec 9, 2021
• Actual Study Completion Date: Dec 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Curie	Paris		France	75005

Sponsors and Collaborators

• Institut Curie

Investigators

• Principal Investigator: Fromantin Isabelle, PhD, Institut Curie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Curie
• ClinicalTrials.gov Identifier: NCT04541537
• Other Study ID Numbers: IC 2020 08
• First Posted: Sep 9, 2020
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 3, 2022