Back to resultsIsolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer (KDOG2)
Primary Purpose
Breast Cancer, Surgery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sorbstar®
Odour sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast, Volatile organic compounds
Eligibility Criteria
Inclusion Criteria:
- Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
- Of-Age female patient (over 18 years old)
- Life expectancy > to 1 year at the inclusion
- Performance status: 0 or 1 or 2
- Patient benefiting from the social security
- Signature informed consent of the study
Exclusion Criteria:
- Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
- Wound presence on breasts
- Male subjects
- Specified metastatic breast cancer
- Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
- Persons under guardianship or deprived of liberty
- Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
Sites / Locations
- INSTITUT CURIE - Site de Saint Cloud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sorbstar®
Dog detection
Arm Description
Odour sampling: Rub hands with Sorbstar® before and post-surgery
Odour sampling: Sleep over a night with a compress on the affected breast before and after surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03703557
Brief Title
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
Acronym
KDOG2
Official Title
Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Surgery
Keywords
Breast, Volatile organic compounds
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Interventional, prospective, open, monocentric study with risks and minimal constraints
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorbstar®
Arm Type
Experimental
Arm Description
Odour sampling: Rub hands with Sorbstar® before and post-surgery
Arm Title
Dog detection
Arm Type
Experimental
Arm Description
Odour sampling: Sleep over a night with a compress on the affected breast before and after surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
Sorbstar®
Intervention Description
Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.
Intervention Type
Diagnostic Test
Intervention Name(s)
Odour sampling
Intervention Description
Analyzed by the dogs of Curie Institute at the training centers
Primary Outcome Measure Information:
Title
Ascertain breast cancer olfactive signature (Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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®).
Description
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.
Time Frame
13 months
Title
Ascertain breast cancer detection by the dogs of Curie Institut
Description
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).
Time Frame
13 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
Of-Age female patient (over 18 years old)
Life expectancy > to 1 year at the inclusion
Performance status: 0 or 1 or 2
Patient benefiting from the social security
Signature informed consent of the study
Exclusion Criteria:
Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
Wound presence on breasts
Male subjects
Specified metastatic breast cancer
Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
Persons under guardianship or deprived of liberty
Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman ROUZIER, Phd
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle FROMANTIN, Phd, IDE
Organizational Affiliation
Institut Curie
Official's Role
Study Director
Facility Information:
Facility Name
INSTITUT CURIE - Site de Saint Cloud
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
12. IPD Sharing Statement
Learn more about this trial
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
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