Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Invasive, Breast Cancer, Metastatic
Conditions
Keywords
CTC, Circulating Tumor Cells, Detection, Breast Cancer, Follow-up, Liquid Biopsy, Blood Test
Brief summary
Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up. The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up
Interventions
DEVICEThe DM/DIV ScreenCell is the experimental product studied during this research
The product is not used directly on the subject, but on a blood sample taken from the participant.
Sponsors
ScreenCell
AXELYS SANTE
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Interventional study with minimal risk and constraints (RIPH2) comparative and open, non-randomized, on an in vitro diagnostic medical device. A case-control study with longitudinal, prospective, single-center follow-up.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For all participants : * Female with age greater than or equal to 18 years For participants with metastatic breast cancer: \- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion. For participants with non-metastatic invasive breast cancer: \- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment) For healthy volunteers: * Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest two years before inclusion * Participant with no history of cancer
Exclusion criteria
For all participants: * Male * Age less than 18 years old * Refusal to participate or withdrawal of consent * Pregnant and/or breastfeeding women * Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up. For healthy volunteers: * History of cancer * Detection of CTC (positive profile) during screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the kinetics of CTC during treatment | From enrollement to the end of follow up at 9 months | Evolution of the number of CTC isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients. Average number of CTCs measured during the study (D0, W6, W12, W24, W36) with a tolerance of +/- 8 days for the visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Molecular characterisation of CTC | From enrollement to the end of follow up at 9 months | Analysis of the expression of specific antigens and the presence of informative mutations on CTCs isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients during the study (D0, W6, W12, W24, W36) |
Countries
France
Contacts
CONTACTJessica GROULT, Ph.D
CONTACTSina NASERIAN, Ph.D
Outcome results
None listed