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

NCT ID: NCT04541537

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2021-12-20

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).

Conditions

Breast Cancer; Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Sorbstar®

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

Group Type: EXPERIMENTAL

Sorbstar®

Intervention Type: DIAGNOSTIC_TEST

Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry

Dog Detection

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

Group Type: EXPERIMENTAL

Dog Detection

Intervention Type: DIAGNOSTIC_TEST

Analysed by the dogs of Curie Institute at the training centers

Interventions

Sorbstar®

Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry

Intervention Type: DIAGNOSTIC_TEST

Dog Detection

Analysed by the dogs of Curie Institute at the training centers

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fromantin Isabelle, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Institut Curie

Paris, , France

Countries

France

References

Leemans M, Cuzuel V, Bauer P, Baba Aissa H, Cournelle G, Baelde A, Thuleau A, Cognon G, Pouget N, Guillot E, Fromantin I, Audureau E. Screening of Breast Cancer from Sweat Samples Analyzed by 2-Dimensional Gas Chromatography-Mass Spectrometry: A Preliminary Study. Cancers (Basel). 2023 May 26;15(11):2939. doi: 10.3390/cancers15112939.

Reference Type: RESULT

PMID: 37296901 (View on PubMed)

Other Identifiers

IC 2020 08

Identifier Type: -

Identifier Source: org_study_id