Breast Cancer Clinical Trial
— MACSSIOfficial title:
Evaluation of Stem and Immune Cells in the Early Stage Breast Cancer Without Genetic Risk
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 15, 2024 |
Est. primary completion date | February 22, 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B | Functional test: mammosphere | Within one month after inclusion (date of surgery) | |
Secondary | Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B | Functional test: TDLU | Within one month after inclusion (date of surgery) | |
Secondary | Functional characterization, after solitary confinement, of stem cells and immune system cells from groups A and B | Functional test: E-CFC - FACS | Within one month after inclusion (date of surgery) | |
Secondary | Determination of the stem cells role in the cellular regulation and repair activity | Functional tests | Within one month after inclusion (date of surgery) | |
Secondary | Determination of the efficacy of the immune systems cells found in the samples in the early stage of breast tumorigenesis | FACS | Within one month after inclusion (date of surgery) | |
Secondary | Evaluation of the role of breast stem and immune cells in the early stage development of a breast cancer: risk or protective factor ? | Functional tests: mammosphere, TDLU, E-CFC - FACS | Within one month after inclusion (date of surgery) |
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