NCT02876497

Brief Summary

Surgical samples of human primitive breast: Representative and various surgical samples of human primitive breast carcinoma in terms of histological type. Moreover, healthy tissue from the same patient will be analysed in parallel. Adjacent normal epithelial structures will be defined as at least 5 mm away from the tumor and histologically normal in appearance. Isolation, differentiation of human monocyte-derived Macrophages (Mphs) and determination of the Macrophage (Mph) migration mode : Human Mphs will be differentiated from blood monocytes isolated from the same patient than the tumor sample. Blood samples will be obtained following standard ethical procedures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2016

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

July 28, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 13, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 28, 2016

Last Update Submit

September 12, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Analysis of Breast Tumor sample

    analysis of the sensitivity to inhibitors

    up to 2 years

  • Analysis of Breast Tumor sample

    analysis of the cell morphology

    up to 2 years

Study Arms (1)

Study arm

EXPERIMENTAL
Other: Define macrophages migration mode

Interventions

Define macrophages migration modeOTHER

Archival tumor samples analysis and blood sample testing

Study arm

Eligibility Criteria

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

You may qualify if:

  • Female patient with breast cancer
  • Age \> 18 years old
  • Available primary breast tumor sample with adjacent normal epithelial structures
  • Informed consent obtained and signed

You may not qualify if:

  • Primary tumor size \< 1cm
  • Surgical tumor sample without available adjacent normal epithelial structures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Florence Dalenc, Dr

    Institut Claudius Regaud

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Dalenc, Dr

CONTACT

dalenc.florence@ouct-oncopole.fr

Muriel Mounier

CONTACT

mounier.muriel@iuct-oncopole.fr

Study Design

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

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 23, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 13, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Specific data base