Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL

NCT ID: NCT05958134

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-06-06

Brief Summary

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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

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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.

Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guilherme Fleury Perini

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

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Research Site

Belo Horizonte, , Brazil

Site Status

Research Site

Recife, , Brazil

Site Status

Research Site

Salvador, , Brazil

Site Status

Research Site

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BRA-DLBCL

Identifier Type: OTHER

Identifier Source: secondary_id

D133HR00022

Identifier Type: -

Identifier Source: org_study_id

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