Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL
2 other identifiers
observational
600
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2023
CompletedStudy Start
First participant enrolled
July 15, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2024
CompletedMay 23, 2025
May 1, 2025
11 months
July 4, 2023
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Disease staging
Description of the staging of diffuse large B-cell lymphoma conditions in patients followed in Brazilian reference cancer treatment centers
Time Frame: 6 years (Time of retrospective observational analysis of the study)
Time between diagnosis and start of treatment
Description of the time between diagnosis and start of treatment
Time Frame: 6 years (Time of retrospective observational analysis of the study)
Progression-free Survival
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
Time Frame: 6 years (Time of retrospective observational analysis of the study)
Overall Survival
Overall Survival will be evaluated as the time from the diagnosis of the hematological disease at any staging until all-cause death
Time Frame: 6 years (Time of retrospective observational analysis of the study)
Study Arms (1)
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).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Hospital Israelita Albert Einsteincollaborator
Study Sites (4)
Research Site
Belo Horizonte, Brazil
Research Site
Recife, Brazil
Research Site
Salvador, Brazil
Research Site
São Paulo, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guilherme Fleury Perini
Hospital Israelita Albert Einstein
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2023
First Posted
July 24, 2023
Study Start
July 15, 2023
Primary Completion
June 6, 2024
Study Completion
June 6, 2024
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.