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| Name | Class |
|---|---|
| AXELYS SANTE | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Donor | Active Comparator | Participants with no prior history of cancer and confirmed to be cancer-free at the time of inclusion, as evidenced by a negative mammogram performed within two years before enrollment |
|
| Metastatic | Experimental | Participants with metastatic breast cancer or metastatic relapse of previously treated breast cancer with change of therapeutic line at the time of study inclusion, confirmed by a POSITIVE PET-Scan |
|
| No metastatic | Experimental | Participants with invasive breast cancer but non-metastatic, confirmed by PET scan or mammography (confirmation not mandatory) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The DM/DIV ScreenCell is the experimental product studied during this research | Device | The product is not used directly on the subject, but on a blood sample taken from the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the kinetics of CTC during treatment | 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 | From enrollement to the end of follow up at 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular characterisation of CTC | 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) | From enrollement to the end of follow up at 9 months |
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INCLUSION CRITERIA
For all participants :
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:
EXCLUSION CRITERIA
For all participants:
For healthy volunteers:
Only individuals who self-identify as female are eligible to participate to evaluate breast cancer within a homogenized cohort, ensuring more relevant and reliable biostatistical analyses
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica GROULT, Ph.D | Contact | 0033669645318 | jgroult@screencell.com | |
| Sina NASERIAN, Ph.D | Contact | snaserian@screencell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMC Ambroise Paré Hartmann | Recruiting | Neuilly-sur-Seine | 92200 | France |
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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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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