Skip to main content
OpenTrials
Completed

NCT Number: NCT05958134

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Belo Horizonte, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Disease staging

    Time frame: 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

  2. Time between diagnosis and start of treatment

    Time frame: Time Frame: 6 years (Time of retrospective observational analysis of the study)

    Description of the time between diagnosis and start of treatment

  3. Progression-free Survival

    Time frame: 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

  4. Overall Survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Hospital Israelita Albert Einstein

Registry information

Official study title

Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL: Multicenter Retrospective Study (Real World Evidence - RWE)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2023
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.