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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This trial is a translational, prospective, open-label, monocentric research.
The study will be conducted in a population of 60 patients with diffuse large B-cell lymphoma (DLBCL) for whom first-line treatment with R-CHOP is planned as part of their standard of care.
SIMILY program aims at identifying biomarkers and/or molecular signatures related to immuno-phenotypic and -genotypic characteristics of the tumor and immune microenvironment, at the time of diagnosis, during R-CHOP, and at 24 months or time of progression.
Each patient will be followed during 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with histologically confirmed diffuse large B-cell lymphoma | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP. | Other | Blood samples will be collected :
Tumor samples will be collected at baseline (from an archived initial diagnostic tumor specimen) and at the time of progression (if applicable from lymph node biopsy performed as part of a standard of care surgical procedure). Bone marrow samples will be collected at baseline and at the time of progression (if applicable) only in patients for whom a bone marrow aspiration (BMA) is necessary as part of their standard of care, upon physician's decision. |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of ctDNA to determine if it reflect the disease evolution of patient with DLBCL treated in first line. | 24 months for each patient | |
| Levels of tumor tissue biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line. | Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS. | 24 months for each patient |
| Levels of blood biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line. | Blood biomarkers will be identified by ScRNA sequencing. | 24 months for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of tumor tissue biomarkers compared to clinical data in the prediction of treatment response. | Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS. | 24 months for each patient |
| Levels of blood biomarkers compared to clinical data in the prediction of treatment response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire du Cancer Toulouse - Oncopole | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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|
Blood biomarkers will be identified by ScRNA sequencing. |
| 24 months for each patient |
| Levels of ctDNA compared to conventional PET imaging (at the standard time points) in the prediction of treatment response. | 24 months for each patient |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |