Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL
Study Details
Study Description
Brief Summary
National, multicenter, non-randomized, retrospective observational study (Real World Evidence-RWE) to analyze the epidemiological profile of diffuse large B cell lymphoma, clinical management, treatment in molecular subgroups, progression profile and patient survival outcomes enrolled and treated within the last 6 years (2017 to 2022), in national cancer reference centers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Diffuse large B-cell lymphoma management is a challenge in clinical setting, as the heterogeneity of conditions due to the molecular complexity of DLBCL may limit treatment response. Other major factor is that in Brazil we lack evidence of treatment response profiling regarding this molecular complexity. To know the epidemiological profile of DLBCL, together with the first-line treatment profile that has been adopted in reference centers, as well as the management of relapsing, is essentially important in generating evidence that add up to actions targeting the improvement of patient care, providing them with better treatments. The Brazilian reality of clinical presentation, management profile, employed treatments and response rate is little known. Considering the Brazilian reality of a continental country, where healthcare services in reference centers present heterogeneous realities, analyzing clinical routine data may generate important evidence (RWE) to comprise the understanding on treatments effectiveness. Generated evidence has the potential to help understanding the reality of Brazilian patients, as well as supporting new regional researches.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diagnosed with diffuse large B-cell lymphoma, and classified regarding the cell of origin Retrospective data collection will be carried out from the medical records of the participants included in the study. Will be held description of the epidemiological profile and pathological staging of diffuse large B-cell lymphoma conditions (DLBCL/LDGCB), imaging profiling, together with first-line treatment used in subgroups of germinal center or activated B-cell, in patients followed in Brazilian reference cancer treatment centers, within the last 6 years (between 2017 and 2022). |
Outcome Measures
Primary Outcome Measures
- Disease staging [Time Frame: 6 years (Time of retrospective observational analysis of the study)]
Description of the staging of diffuse large B-cell lymphoma conditions in patients followed in Brazilian reference cancer treatment centers
- Time between diagnosis and start of treatment [Time Frame: 6 years (Time of retrospective observational analysis of the study)]
Description of the time between diagnosis and start of treatment
- Progression-free Survival [Time Frame: 6 years (Time of retrospective observational analysis of the study)]
Progression-free Survival will be evaluated as the time from the beginning of treatment, considering each line of treatment, to the objective progression of tumor or death
- Overall Survival [Time Frame: 6 years (Time of retrospective observational analysis of the study)]
Overall Survival will be evaluated as the time from the diagnosis of the hematological disease at any staging until all-cause death
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female;
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Age above 18 years old;
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Diagnosis of diffuse large B-cell lymphoma (DLBCL) and high-grade non-Hodgkin B-cell lymphoma at all stagings;
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Lymphoma classified for the cell of origin (GCB - Germinal Center B-Cell lymphoma, and non-germinal center);
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Having first life of treatment information available in institutional medical record;
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Having survival data available in institutional medical record.
Exclusion Criteria:
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No medical record of the molecular subgroup classification;
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Diagnosis of diffuse large B-cell lymphoma, confirmed in the year 2016;
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Patients diagnosed with Transformed Lymphomas.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidade Federal da Bahia | Salvador | Bahia | Brazil | 40110-060 |
| 2 | Ensino e Terapia de Inovação Clinica AMO-ETICA | Salvador | Bahia | Brazil | 41950-640 |
| 3 | Instituto Mário Penna - Ensino Pesquisa e Inovação | Belo Horizonte | Minas Gerais | Brazil | 30380-472 |
| 4 | Instituto de Medicina Integral Professor Fernando Figueira - IMIP | Recife | Pernambuco | Brazil | 50070-902 |
| 5 | Centro de Pesquisas Oncológicas - CEPON | Florianópolis | Santa Catarina | Brazil | 88034-000 |
| 6 | Hospital Universitário de Botucatu | Botucatu | São Paulo | Brazil | 18618-686 |
| 7 | Instituto Nacional de Câncer - INCA | Rio De Janeiro | Brazil | 20230-130 | |
| 8 | Hospital Municipal da Vila Santa Catarina | São Paulo | Brazil | 04378-500 | |
| 9 | Hospital Israelita Albert Einstein | São Paulo | Brazil | 05652-900 | |
| 10 | AC Camargo Câncer Center | São Paulo | Brazil | 1509-001 |
Sponsors and Collaborators
- Hospital Israelita Albert Einstein
- AstraZeneca
Investigators
- Principal Investigator: Guilherme Fleury Perini, Hospital Israelita Albert Einstein
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRA-DLBCL