- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03703557
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer (KDOG2)
Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Saint-Cloud, France, 92210
- INSTITUT CURIE - Site de Saint Cloud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sorbstar®
Odour sampling: Rub hands with Sorbstar® before and post-surgery
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Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.
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EXPERIMENTAL: Dog detection
Odour sampling: Sleep over a night with a compress on the affected breast before and after surgery
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Analyzed by the dogs of Curie Institute at the training centers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ascertain breast cancer olfactive signature (Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®)
Time Frame: 12 months
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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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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: 13 months
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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.
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13 months
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Ascertain breast cancer detection by the dogs of Curie Institut
Time Frame: 13 months
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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).
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13 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roman ROUZIER, Phd, Institut Curie
- Study Director: Isabelle FROMANTIN, Phd, IDE, Institut Curie
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC 2018-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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