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

Breast Cancer Clinical Trial

— KDOG2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703557
• Other study ID #: IC 2018-01
• Status: Completed
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: September 20, 2020

Study information

• Verified date: December 2020
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To ascertain the possibilities to isolate the breast cancer olfactive signature.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 20, 2020
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

Intervention

Diagnostic Test:
• Sorbstar®
Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.
• Odour sampling
Analyzed by the dogs of Curie Institute at the training centers

Locations

Country	Name	City	State
France	INSTITUT CURIE - Site de Saint Cloud	Saint-Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascertain breast cancer olfactive signature (Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®)	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.	12 months
Secondary	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.	13 months
Secondary	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).	13 months