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

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ClinicalTrials.gov Identifier: NCT04541537
Recruitment Status : Completed
First Posted : September 9, 2020
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Experimental, 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 : January 25, 2021
Actual Primary Completion Date : December 9, 2021
Actual Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. To ascertain the possibilities to isolate the breast cancer olfactive signature [ Time Frame: 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®) [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541537


Locations
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France
Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Fromantin Isabelle, PhD Institut Curie
More Information
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04541537    
Other Study ID Numbers: IC 2020 08
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases