Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL
- Conditions
- Diffuse Large B Cell Lymphoma
- Registration Number
- NCT05958134
- Lead Sponsor
- AstraZeneca
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- Male and female;
- Age above 18 years old;
- Diagnosis of diffuse large B-cell lymphoma (DLBCL) and high-grade non-Hodgkin B-cell lymphoma at all stagings;
- Lymphoma classified for the cell of origin (GCB - Germinal Center B-Cell lymphoma, and non-germinal center);
- Having first life of treatment information available in institutional medical record;
- Having survival data available in institutional medical record.
- No medical record of the molecular subgroup classification;
- Diagnosis of diffuse large B-cell lymphoma, confirmed in the year 2016;
- Patients diagnosed with Transformed Lymphomas.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇧🇷Sao Paulo, Brazil