NCT03870802

Brief Summary

Monocentric, observational and prospective study in adult women having an early-stage breast cancer without genetic risk. The main objective is to characterize quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland in women:

  • With a moderate risk of breast cancer progression (women with an early "Luminal A" tumor) = Group A.
  • With a high risk of breast cancer progression (women with an early "Luminal B" or basal tumor) = Group B.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

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

September 25, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

September 25, 2018

Last Update Submit

January 24, 2024

Conditions

Breast Cancer

Keywords

Breast cancerStem cellsImmune cells

Outcome Measures

Primary Outcomes (1)

  • To characterise quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland according to the risk of breast cancer progression (group A and B)

    Rate of stem and immune cells and phenotype analysis

    Within one month after inclusion (date of surgery)

Secondary Outcomes (6)

  • Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B

    Within one month after inclusion (date of surgery)

  • Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B

    Within one month after inclusion (date of surgery)

  • Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B

    Within one month after inclusion (date of surgery)

  • Determination of the stem cells role in the cellular regulation and repair activity

    Within one month after inclusion (date of surgery)

  • Determination of the efficacy of the immune systems cells found in the samples in the early stage of breast tumorigenesis

    Within one month after inclusion (date of surgery)

  • +1 more secondary outcomes

Interventions

Characterization of breast stem & immune system cells infiltrated in the mammary glandOTHER

Isolation, quantification and characterization of breast stem and immune cells of samples obtained during the prophylactic mastectomy in women presenting different tumor progression risks.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult women having an early-stage breast cancer without genetic risk
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult women having an early-stage breast cancer without genetic risk requiring a breast surgery

You may qualify if:

  • Age ≥ 18 years
  • Patient requiring a breast surgery (total mastectomy) of an early stage tumour classified as :
  • Luminal A (Arm A) : Patients with a moderate risk of breast cancer progression or,
  • Luminal B or Basal (Arm B) : Patients with a high risk of breast cancer progression
  • Systemic treatment not initiated
  • Breast cup size ≥ C
  • Informed and signed consent.

You may not qualify if:

  • Neo-adjuvant chemotherapy or hormonotherapy
  • History of breast irradiation
  • Pregnant or breastfeeding woman
  • Patient under tutorship or curatorship
  • Patient who underwent a lumpectomy with a level-2 oncoplastic surgery (ex: breast reduction with an inverted-T remodeling)
  • Any other prior anti-tumor treatment
  • Other medical pathology which may interfere with the biologic evaluation, especially chronic auto-immune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast tissue samples obtained during the prophylactic mastectomy

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • DELAY Emmanuel, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DELAY Emmanuel, MD

CONTACT

+33 4.78.78.51.29emmanuel.delay@lyon.unicancer.fr

DAMMACCO Delia, MD

CONTACT

+33 4.78.78.27.76maria-adele.dammacco@lyon.unicancer.fr

Study Design

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

Study Record Dates

First Submitted

September 25, 2018

First Posted

March 12, 2019

Study Start

February 22, 2021

Primary Completion

February 22, 2024

Study Completion

November 15, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations

FR(1)