Breast CancerKDOG2NCT03703557
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
A study testing Sorbstar® and Odour sampling 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 only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- Sorbstar® and Odour sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2018to 20 Sep 2020
- 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
- No healthy volunteers
- 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
- 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
- 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®, Odour sampling
- Keywords
- Breast, Volatile organic compounds
- 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.
Odour samplingDiagnostic test
Analyzed by the dogs of Curie Institute at the training centers
| Study group | Role | What they receive |
|---|---|---|
| Sorbstar® | Experimental | Odour sampling: Rub hands with Sorbstar® 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: Odour sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 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: 13 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: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start25 Jul 2018
- Primary completion20 Sep 2019
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional, prospective, open, monocentric study with risks and minimal constraints
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman ROUZIER, Phd, Principal investigator, Institut CurieIsabelle FROMANTIN, Phd, IDE, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703557
- Sponsor's protocol ID
- IC 2018-01
- Acronym
- KDOG2
- Status last verified
- Dec 2020
- First submitted
- 10 Jul 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. 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
- NCT03703557
- Acronym / sponsor ID
- KDOG2 / IC 2018-01
- Conditions
- Breast Cancer, Surgery
- Keywords
- Breast, Volatile organic compounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 12 Oct 2018 (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
- Interventional, prospective, open, monocentric study with risks and minimal constraints
| Arm | Type | Receives |
|---|---|---|
| Sorbstar® | Experimental | Diagnostic Test: Sorbstar®Odour sampling: Rub hands with Sorbstar® before and post-surgery |
| Dog detection | Experimental | Diagnostic Test: Odour samplingOdour 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
- Not 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
- Performance status: 0 or 1 or 2
- Patient benefiting from the social security
Key exclusion criteria (7 listed)
- 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)
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® |
| Odour samplingAnalyzed by the dogs of Curie Institute at the training centers | Diagnostic test | Dog detection |
Primary outcome
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
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: 13 months
Ascertain breast cancer detection by the dogs of Curie Institut
Time frame: 13 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 Dec 2020.
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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.
Roman ROUZIER, Phd principal investigator
Institut Curie
Isabelle FROMANTIN, Phd, IDE study director
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 Odour sampling 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 7 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 Dec 2020. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2020.