NCT04217109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

July 14, 2023

Status Verified

June 1, 2022

Enrollment Period

3.2 years

First QC Date

November 19, 2019

Last Update Submit

July 13, 2023

Conditions

Breast Cancer

Keywords

Breast cancerDog DetectionVolatile organic Compounds

Outcome Measures

Primary Outcomes (1)

  • 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)

    26 months

Secondary Outcomes (8)

  • Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)

    38 months

  • Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology

    38 months

  • Patient compliance during the study

    26 months

  • Comparison between canine odorology and mammography

    38 months

  • Performance of each dog

    26 months

  • +3 more secondary outcomes

Study Arms (1)

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).

Diagnostic Test: Odour sampling

Interventions

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.

Odour sampling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ;

You may not qualify if:

  • Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
  • Patient with breast implant(s);
  • Patient with a breast skin ulceration;
  • Patient under insulin (risk of sudation that may impair compress sample);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre République

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Universitaire

Limoges, 87000, France

Location

Institut de Cancérologie de l'Ouest

Nantes, 44, France

Location

Groupe Hospitalier Paris Saint- Joseph

Paris, 75, France

Location

Institut Curie

Paris, 75, France

Location

Institut Curie

Saint-Cloud, 92, France

Location

Centre Hospitalier Valenciennes

Valenciennes, 59, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ANNE TARDIVON, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

January 3, 2020

Study Start

February 3, 2020

Primary Completion

April 25, 2023

Study Completion

April 25, 2023

Last Updated

July 14, 2023

Record last verified: 2022-06

Locations

FR(7)