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| ID | Type | Description | Link |
|---|---|---|---|
| RF-2016-02363730 | Other Grant/Funding Number | Italian Ministry of Health |
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In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gut microbiota samples | Other | Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy |
| Measure | Description | Time Frame |
|---|---|---|
| GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients) |
| 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response to therapy | Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative and all lymph nodes and nodal masses must have regressed on CT to normal size ( 1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients affected by diffuse large B-cell lymphoma (DLBCL) undergoing therapy with front-line R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone).
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| Name | Affiliation | Role |
|---|---|---|
| Pier Luigi L Zinzani, Professor | Institute of Hematology "L. e A. Serà gnoli", University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) | Meldola | FC | Italy | |||
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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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Gut microbiota
| 2 years |
| Institute Of Hematology "Serà gnoli" |
| Bologna |
| 40138 |
| Italy |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |