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Transcutaneous Breast Cancer Diagnosis by Canine Odorology (KDOG1)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Odour sampling
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, Dog Detection, Volatile organic Compounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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) ;
  2. Benefit from the national social security ;
  3. Signature of the informed consent of the study ;
  4. There is no contraindication for the person to simultaneously participate to another research program and there is no exclusion period planned after the study.

Exclusion Criteria:

  1. Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
  2. Patient with breast implant(s);
  3. 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;
  4. 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;
  5. Patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion;
  6. Patient with a breast skin ulceration;
  7. Patient under insulin (risk of sudation that may impair compress sample);
  8. Concomitant antibiotics or corticoids taken one week before inclusion in the study;
  9. Patient with a current viral infection (fever);
  10. Persons under guardianship or deprived of liberty;
  11. Impossibility to submit to the medical monitoring expected by the study for geographical or severe psychological reasons.

Sites / Locations

  • Centre République
  • Centre Hospitalier Universitaire
  • Institut de Cancérologie de l'Ouest
  • Groupe Hospitalier Paris Saint- Joseph
  • Institut Curie
  • Institut Curie
  • Centre Hospitalier Valenciennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Odour sampling

Arm Description

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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
Patient compliance during the study
The rate of return of compresses after delivery of a kit will be evaluated
Comparison between canine odorology and mammography
Comparison test of sensitivity and specificity values between canine odorology and mammography
Performance of each dog
Sensitivity and specificity of canine odorology for each dog will be calculated
Variability between dogs
A Cohen's kappa test will be used to explore the variability between trained dogs and dog breeds
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
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.

Full Information

First Posted
November 19, 2019
Last Updated
July 13, 2023
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT04217109
Brief Title
Transcutaneous Breast Cancer Diagnosis by Canine Odorology
Acronym
KDOG1
Official Title
KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
April 25, 2023 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Dog Detection, Volatile organic Compounds

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Odour sampling
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Odour sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the sensitivity and specificity of canine odorology in women with breast lesion
Description
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)
Time Frame
26 months
Secondary Outcome Measure Information:
Title
Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)
Description
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.
Time Frame
38 months
Title
Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology
Description
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
Time Frame
38 months
Title
Patient compliance during the study
Description
The rate of return of compresses after delivery of a kit will be evaluated
Time Frame
26 months
Title
Comparison between canine odorology and mammography
Description
Comparison test of sensitivity and specificity values between canine odorology and mammography
Time Frame
38 months
Title
Performance of each dog
Description
Sensitivity and specificity of canine odorology for each dog will be calculated
Time Frame
26 months
Title
Variability between dogs
Description
A Cohen's kappa test will be used to explore the variability between trained dogs and dog breeds
Time Frame
26 months
Title
Performance of canine odorology if the test is based on 2 dogs
Description
The results of the 2 dogs will be used to compare the performances
Time Frame
24 months
Title
Patient's satisfaction
Description
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.
Time Frame
26 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANNE TARDIVON, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre République
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
ZIP/Postal Code
44
Country
France
Facility Name
Groupe Hospitalier Paris Saint- Joseph
City
Paris
ZIP/Postal Code
75
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75
Country
France
Facility Name
Institut Curie
City
Saint-Cloud
ZIP/Postal Code
92
Country
France
Facility Name
Centre Hospitalier Valenciennes
City
Valenciennes
ZIP/Postal Code
59
Country
France

12. IPD Sharing Statement

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Transcutaneous Breast Cancer Diagnosis by Canine Odorology

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