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recruitment difficulties
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B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was associated with poor response to chemotherapy. However, few studies have been done on childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its significance has never been evaluated in human cancers. The purpose of this study is to prospectively evaluate the immune status of children newly diagnosed with first relapse of B-cell ALL, and to compare results with those of children treated for B-ALL in complete remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of immunosuppressive cells proportions could be associated with B-ALL relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapse Group | Other |
|
|
| Control Group | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of blood samples | Biological | Collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Treg (CD4+,CD25+, Foxp3+) and deficient natural killer (NK) cells (CD3-,CD56+,NKp30-) proportions by FACS in children newly diagnosed with their first relapse of B-ALL. | Comparison of the immune status of patients at the diagnosis of their first relapse diagnosis with those of children treated for B-ALL who are in complete remission and at the same stage of treatment. | At the time of the inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the number of T CD4+ lymphocytes (Cluster of Differentiation 4), T CD8+ lymphocytes (Cluster of Differentiation 8), NK cells and Natural killer T (NKT) cells by FACS. | At the time of the inclusion. | |
| Measure of percentage of TCD4+ naive and memory cells and TCD8+ naive and memory cells by FACS. |
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Inclusion Criteria for relapse Group :
Inclusion Criteria for control Group :
Exclusion criteria for control Group are the same as for relapsed Group :
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle PELLIER, PU-PH | UNIVERSITY HOSPITAL OF ANGERS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Amiens | Amiens | 80054 | France | |||
| University Hospital of Angers |
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| At the time of the inclusion. |
| Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS. | At the time of the inclusion. |
| Measure of TRECs (T cell receptor excision circle) by QPCR and naïve CD4+CD45RA+CD31+ T cells by FACS. | At the time of the inclusion. |
| Angers |
| 49933 |
| France |
| University Hospital of Besancon | Besançon | 25030 | France |
| University Hospital of Bordeaux | Bordeaux | 33000 | France |
| University Hospital of Caen | Caen | 14033 | France |
| Civil Hospices of Lyon | Lyon | 69008 | France |
| University Hospital of Marseille | Marseille | 13385 | France |
| University Hospital of Nancy | Nancy | 54511 | France |
| University Hospital of Nantes | Nantes | 44000 | France |
| University Hospital of Nice | Nice | 06202 | France |
| University Hospital of Trousseau (Paris) | Paris | 75571 | France |
| University Hospital of Robert Debre (Paris) | Paris | 75935 | France |
| University Hospital of Reims | Reims | 51092 | France |
| University Hospital of Rennes | Rennes | 35203 | France |
| University Hospital of Saint Etienne | Saint-Etienne | 42055 | France |
| University Hospital of Strasbourg | Strasbourg | 67098 | France |
| University Hospital of Toulouse | Toulouse | 31059 | France |
| University Hospital of Tours | Tours | 37000 | France |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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