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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02900-57 | Other Identifier | ID RCB |
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This study aim to determine kinetic of post treatment recovery/variation of a panel of innate and adaptative immune system cells and molecules.
The results should allow to determine the optimal post treatment immunomonitoring timing and panel to be used for future studies.
There is a complexe interaction between tumor cells ans host immunity. Immunity system (IS) is clearly involved in cancer developement control, and it is suggested that it could participate to the response to anti cancer treatment.
There is however no validated immunomonitoring strategy to allow a reliable patient's immune status along time, and particularly after treatment.There are scarce existing information on immunologic reconstitution profile recovery after treatment.
This study aim to perform immunomonitoring in young patients with cancer to describe kinetic of recovery/variation of a panel of innate and adaptative immune system cells and molecules, selected by their potential relevance according to literature.
The concerned population are young women (Ë‚40 yo) with breast cancer.
There will be 2 patients cohorts A or "End of treatment" : patients recruited at the end of treatment (study cohort) B or "Diagnosis" : Patients recruited at diagnosis (reference values)
This study should contribute to give sufficient data to determine the pertinent timing and cells/molecules panel to evaluate immunity profiling after treatment.
These results could be used for further studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A or "End of treatment" | 16 patients recruited at the end of breast cancer treatment and followed during 9 months |
| |
| Cohort B or "Diagnosis" | Patients recruited at breast cancer before any treatment: one blood sample to provide comparative values. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunomonitoring | Biological | 16 patients will be recruited at the end of treatment: an immunoprofiling analysis will be performed out of a blood sample about 1 month, 5 months and 9 months after treatment. 8 patients will be recruited at diagnosis: a immune profile analysis will be performed before the start of treatment. This will give comparative values for the immune system cells and molecules. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the relevant biological parameters of the innate / adaptive immune system | Analysis of immune profile implies to evaluate changes of about 30 distinct immune cell (sub)types with their activation markers. These analyses are conducted at 3 time points for cohort "A or End of treatment" (1, 5, 9 months) and once for cohort "B or Diagnosis" before treatment start : -% and counts of immune cell populations (B-lymphocytes, T-lymphocytes, dendritic cells)
| 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis feasibility | number of samples analysed versus planned, quality of the results | 15 months |
| Immunity Cells and molecules kinetic analysis | The objective is to determine the best moment for analysis of immune system reconstitution (cf outcome 1 measures) For each patient, and each immune system marker tested (cells/molecules): kinetic analysis of return to values comparable to reference values (data from the EFS = french blood establishment and the 8 patients tested before the start of treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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Women with breast cancer and systemic treatments planed or done aged 18 to 39
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leila Gofti-Laroche, PharmD | Contact | 0033 4 76 76 68 74 | LGofti-laroche@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Leila Gofti-Laroche, PharmD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Grenoble Alpes | Recruiting | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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blood samples that will be destroyed after publications.
|
| 15 months |
| D017437 |
| Skin and Connective Tissue Diseases |