Breast CancerKDOG1NCT04217109
Transcutaneous Breast Cancer Diagnosis by Canine Odorology
A study testing Odour sampling in people with Breast Cancer, run by Institut Curie at 7 sites in France.
Trial summary
Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Odour sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 7 sitesFrance
- Study dates
- 3 Feb 2020to 25 Apr 2023
- 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
- Women 18 years and older, with one or more ipsilateral mammary lesion(s), palpable or not, detected at mammography and/or ultrasound and with at least one lesion classified as BI-RADS® category 4 or 5 with an indication of percutaneous sampling (cytology, microbiopsies, macro-biopsies) ;
- Benefit from the national social security ;
- Signature of the informed consent of the study ;
- There is no contraindication for the person to simultaneously participate to another research program and there is no exclusion period planned after the study.
Who cannot join
- Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
- Patient with breast implant(s);
- Patient with a personal history of breast surgery for benign lesion(s) of the concerned breast operated less than 4 weeks before the date of inclusion in this study;
- Patient with a personal history of cancer (in situ or invasive) less than 5 years before inclusion whatever the anatomical site including cutaneous basal cell carcinoma;
- Patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion;
- Patient with a breast skin ulceration;
Show all 11Show fewer
- Patient under insulin (risk of sudation that may impair compress sample);
- Concomitant antibiotics or corticoids taken one week before inclusion in the study;
- Patient with a current viral infection (fever);
- Persons under guardianship or deprived of liberty;
- Impossibility to submit to the medical monitoring expected by the study for geographical or severe psychological reasons.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre République
Clermont-Ferrand, 63000
Centre Hospitalier Universitaire
Limoges, 87000
Institut de Cancérologie de l'Ouest
Nantes, 44
Groupe Hospitalier Paris Saint- Joseph
Paris, 75
Institut Curie
Paris, 75
Institut Curie
Saint-Cloud, 92
Centre Hospitalier Valenciennes
Valenciennes, 59
About this study
Official title: KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology
Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast ultrasound examination.
- Conditions
- Breast Cancer
- Being tested
- Odour sampling
- Keywords
- Breast cancer, Dog Detection, 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.
Odour samplingDiagnostic test
Upon receipt of the samples at the Institute Curie-Paris, the compresses will be packed in jars and then transmitted to the dog center and analyzed by the study dogs.
Positive marking is characterized by a sitting position of the dog in front of the sample.
| Study group | Role | What they receive |
|---|---|---|
| Odour sampling | Experimental | Odour collection will be obtained by positioning a compress on the breast concerned during the night preceding the day of samplings. The compress, once removed, will be placed in specific envelope for the study. Envelope will be given to the investigating centre during the appointment of percutaneous samples and then sent to the sponsor center (Institute Curie Paris). Receives: Diagnostic Test: Odour sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of canine odorology in women with breast lesion
The sensitivity and specificity of canine odorology in women with undeterminate breast lesion classified American College of Radiology (ACR) 4 or 5 (typically malignant) will be compared to the anatomopathological results of breast percutaneous sampling (biopsy)
Measured: 26 months
Secondary outcomes (8)
Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)
Number of markings among compresses of patients affected and number of no-markings among compresses of patients not affected. The gold standard is the pathological examination of the operative specimen or the status of the patient at 1 year.
Measured: 38 months
Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology
Number of compresses of patient affected on number of markings (PPV) and number of compresses of patient non affected on number of no-markings (NPV) will be evaluated
Measured: 38 months
Patient compliance during the study
The rate of return of compresses after delivery of a kit will be evaluated
Measured: 26 months
Comparison between canine odorology and mammography
Comparison test of sensitivity and specificity values between canine odorology and mammography
Measured: 38 months
Performance of each dog
Sensitivity and specificity of canine odorology for each dog will be calculated
Measured: 26 months
Variability between dogs
A Cohen's kappa test will be used to explore the variability between trained dogs and dog breeds
Measured: 26 months
Performance of canine odorology if the test is based on 2 dogs
The results of the 2 dogs will be used to compare the performances
Measured: 24 months
Patient's satisfaction
A questionnaire will be completed by the patients to measure their satisfaction and indicate their level of agreement. A score from 0 (no anxiety) to 5 (very anxious) on a scale will be completed to assess anxiety, a score from 0 (very difficult) to 5 (very easy) will be used to ensure that the compress is easy to use.
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start3 Feb 2020
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANNE TARDIVON, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217109
- Sponsor's protocol ID
- 2019-A01592-55
- Acronym
- KDOG1
- Status last verified
- Jun 2022
- First submitted
- 19 Nov 2019
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology
- ClinicalTrials.gov ID
- NCT04217109
- Acronym / sponsor ID
- KDOG1 / 2019-A01592-55
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Dog Detection, Volatile organic Compounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 3 Jan 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.
Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast ultrasound examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Odour sampling | Experimental | Diagnostic Test: Odour samplingOdour collection will be obtained by positioning a compress on the breast concerned during the night preceding the day of samplings. The compress, once removed, will be placed in specific envelope for the study. Envelope will be given to the investigating centre during the appointment of percutaneous samples and then sent to the sponsor center (Institute Curie Paris). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women 18 years and older, with one or more ipsilateral mammary lesion(s), palpable or not, detected at mammography and/or ultrasound and with at least one lesion classified as BI-RADS® category 4 or 5 with an indication of percutaneous sampling (cytology, microbiopsies, macro-biopsies) ;
- Benefit from the national social security ;
- Signature of the informed consent of the study ;
- There is no contraindication for the person to simultaneously participate to another research program and there is no exclusion period planned after the study.
Key exclusion criteria (11 listed)
- Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
- Patient with breast implant(s);
- Patient with a personal history of breast surgery for benign lesion(s) of the concerned breast operated less than 4 weeks before the date of inclusion in this study;
- Patient with a personal history of cancer (in situ or invasive) less than 5 years before inclusion whatever the anatomical site including cutaneous basal cell carcinoma;
- Patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion;
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 |
|---|---|---|
| Odour samplingUpon receipt of the samples at the Institute Curie-Paris, the compresses will be packed in jars and then transmitted to the dog center and analyzed by the study dogs. Positive marking is characterized by a sitting position of the dog in front of the sample. | Diagnostic test | Odour sampling |
Primary outcome
Evaluate the sensitivity and specificity of canine odorology in women with breast lesion
Time frame: 26 months
The sensitivity and specificity of canine odorology in women with undeterminate breast lesion classified American College of Radiology (ACR) 4 or 5 (typically malignant) will be compared to the anatomopathological results of breast percutaneous sampling (biopsy)
8 secondary outcomes
Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)
Time frame: 38 months
Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology
Time frame: 38 months
Patient compliance during the study
Time frame: 26 months
Comparison between canine odorology and mammography
Time frame: 38 months
Performance of each dog
Time frame: 26 months
Variability between dogs
Time frame: 26 months
Performance of canine odorology if the test is based on 2 dogs
Time frame: 24 months
Patient's satisfaction
Time frame: 26 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 14 Jul 2023.
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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.
ANNE TARDIVON, MD principal investigator
Institut Curie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Odour sampling in people with Breast Cancer, run by Institut Curie at 7 sites 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 4 inclusion and 11 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Evaluate the sensitivity and specificity of canine odorology in women with breast lesion (time frame: 26 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 14 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.