Clinical trial NCT05958134: Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL
Official title: Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL: Multicenter Retrospective Study (Real World Evidence - RWE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Lymphoma; RWE; Diffuse Large B Cell
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Hospital Israelita Albert Einstein
First posted: 2023-07-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed with diffuse large B-cell lymphoma, who meet the eligibility criteria and have been treated and followed in the study participating sites within the last 6 years (from 2017 to 2022) will be included in the study.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disease staging
timeFrame: Time Frame: 6 years (Time of retrospective observational analysis of the study)
measure: Time between diagnosis and start of treatment
timeFrame: Time Frame: 6 years (Time of retrospective observational analysis of the study)
measure: Progression-free Survival
timeFrame: Time Frame: 6 years (Time of retrospective observational analysis of the study)
measure: Overall Survival
timeFrame: Time Frame: 6 years (Time of retrospective observational analysis of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Recife
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Guilherme Fleury Perini
role: PRINCIPAL_INVESTIGATOR
References: