NCT04292821

Brief Summary

Breast cancer is a frequent pathology and the speed of initial diagnosis makes it possible to improve the course of care and to reduce the anxiety of the patients. For a complete assessment, several biopsies may be necessary, including lymph node biopsies. Once the histological sample has been taken, a preparation is necessary (time consuming technician) then a reading by a pathologist requiring at least 48-72h. Cytology allows immediate diagnosis, but it requires the presence of a pathologist in the collection room. Finally, some biopsies can be non-contributory (if there is not enough tissue removed) and require new samples. A tool allowing immediate control of the tissue and an initial diagnosis without mobilizing the pathologist (who will make the result complete with immunohistochemistry) would make it possible to anticipate the next course of care and facilitate treatment. The BIOPSY SCANNER LLTECH © technology would allow images on fresh unprepared tissue to obtain images allowing immediate diagnosis by a non-pathologist, the same tissue could then be technical for a complete analysis by the pathologist. The investigators propose a study evaluating the diagnostic capacities by non pathologists from images obtained by the BIOPSY SCANNER LLTECH © technology on breast and lymph node biopsies. Based on this study, an atlas on breast lesions could be created to allow a broader evaluation of this technology in daily practice in diagnostic of breast pathology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

February 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 28, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

May 27, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

February 28, 2020

Last Update Submit

May 25, 2020

Conditions

Breast Cancer

Keywords

breast lesionbreast cancerB3 breast lesionatypical breast lesionbreast imagingone-day breast diagnosis

Outcome Measures

Primary Outcomes (1)

  • Positive predictive value (PPV)

    Positive predictive value (PPV) of the diagnosis of breast cancer by the analysis of images BIOPSY SCANNER LLTECH © carried out by a senior radiologist taking as reference the results provided by histology on tissue section.

    At the end of inclusion time

Secondary Outcomes (6)

  • Reproductibility

    At the end of inclusion time

  • Efficiency for each histologic type

    At the end of inclusion time

  • Efficiency compared between breast tissue and lymph node

    At the end of inclusion time

  • Progression curve

    At the end of inclusion time

  • Image atlas

    At the end of inclusion time

  • +1 more secondary outcomes

Study Arms (1)

Patients consulting for breast lesion Bi Rads 4 or 5

Patients consulting for breast lesion Bi Rads 4 or 5

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting for breast lesion Bi Rads 4 or 5

You may qualify if:

  • Patients over 18 years old requiring a breast biopsy for an birads 4 or 5 nodular radiological lesion or lymph node for a lymph node judged to be radiologically suspect (cortex thickened by more than 3 mm)

You may not qualify if:

  • Patients under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (1)

  • Simon A, Badachi Y, Ropers J, Laurent I, Dong L, Da Maia E, Bourcier A, Canlorbe G, Uzan C. Value of high-resolution full-field optical coherence tomography and dynamic cell imaging for one-stop rapid diagnosis breast clinic. Cancer Med. 2023 Oct;12(19):19500-19511. doi: 10.1002/cam4.6560. Epub 2023 Sep 29.

    PMID: 37772663DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Catherine UZAN, Md PhD

    Pitié-Salpêtrière Hospital (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine UZAN, Md PhD

CONTACT

01 42 17 81 14catherine.uzan@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 3, 2020

Study Start

April 28, 2020

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

May 27, 2020

Record last verified: 2020-02

Locations

FR(1)