Breast CancerKDOG COVNCT04541537
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer. (KDOGCOV)
A study testing Sorbstar® and Dog Detection in people with Breast Cancer and Surgery, run by Institut Curie at 1 site in France.
Trial summary
To ascertain the possibilities to isolate the breast cancer olfactive signature Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- Sorbstar® and Dog Detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- ECOG performance status: 0 or 1 or 2
- Patient benefiting from the social security
- Signature informed consent of the study
Who cannot join
- Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
- Wound presence on breasts
- Male subjects
- Pregnant or lactating women
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
To ascertain the possibilities to isolate the breast cancer olfactive signature
Read the 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
- Being tested
- Sorbstar®, Dog Detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorbstar®Diagnostic test
Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry
Dog DetectionDiagnostic test
Analysed by the dogs of Curie Institute at the training centers
| Study group | Role | What they receive |
|---|---|---|
| Sorbstar® | Experimental | Odour sampling : rub hands with Sorbstars® before and post-surgery Receives: Diagnostic Test: Sorbstar® |
| Dog Detection | Experimental | Odour sampling :sleep over a night with a compress on the affected breast before and after surgery Receives: Diagnostic Test: Dog Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To ascertain the possibilities to isolate the breast cancer olfactive signature
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.
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 18 months
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start25 Jan 2021
- Primary completion9 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Experimental, interventional, prospective, open, monocentric study with risks and minimal constraints
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fromantin Isabelle, PhD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541537
- Sponsor's protocol ID
- IC 2020 08
- Acronym
- KDOG COV
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37296901
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
- ClinicalTrials.gov ID
- NCT04541537
- Acronym / sponsor ID
- KDOG COV / IC 2020 08
- Conditions
- Breast Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, interventional, prospective, open, monocentric study with risks and minimal constraints
| Arm | Type | Receives |
|---|---|---|
| Sorbstar® | Experimental | Diagnostic Test: Sorbstar®Odour sampling : rub hands with Sorbstars® before and post-surgery |
| Dog Detection | Experimental | Diagnostic Test: Dog DetectionOdour sampling :sleep over a night with a compress on the affected breast before and after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- ECOG performance status: 0 or 1 or 2
- Patient benefiting from the social security
Key exclusion criteria (8 listed)
- Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
- Wound presence on breasts
- Male subjects
- Pregnant or lactating women
- Specified metastatic breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorbstar®Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry | Diagnostic test | Sorbstar® |
| Dog DetectionAnalysed by the dogs of Curie Institute at the training centers | Diagnostic test | Dog Detection |
Primary outcome
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.
2 secondary outcomes
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
Ascertain breast cancer detection by the dogs of Curie Institut
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Results publication: PubMed 37296901Leemans 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fromantin Isabelle, PhD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorbstar® and Dog Detection in people with Breast Cancer and Surgery, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To ascertain the possibilities to isolate the breast cancer olfactive signature (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04541537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.