A Retrospective Study on Extranodal DLBCL

NCT06549361 | Completed

• 1 other identifier: ENI-DLBCL
• Study Type: observational
• Target: 5,023
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.

Conditions

Lymphoma; Extranodal Lymphoma; Diffuse Large B Cell Lymphoma

Keywords

Lymphoma; Extranodal

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.

  Time Frame: Baseline up to data cut-off (up to approximately 1 year)

• Progression Free Survival (PFS)

  Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.

  Time Frame: Baseline up to data cut-off (up to approximately 1 year)

Secondary Outcomes (1)

• Clinical characteristics form

  Baseline up to data cut-off (up to approximately 1 year)

Interventions

No interventions need to be specified for this study OTHER

No interventions need to be specified for this study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement or non-Hodgkin lymphoma of rare pathological types attending participating centres.

You may qualify if:

• \. ≥ 18 years (including 18 years).
• \. Pathologically diagnosed with diffuse large B-cell lymphoma according to the 2016 WHO classification, including non-specific types and various special subtypes.
• \. Newly diagnosed DLBCL with involvement of extranodal organs.
• \. Patients who have received clinical treatment for lymphoma.
• Patients with measurable lesions, including at least one effective efficacy assessment.

You may not qualify if:

• \. Patients receiving supportive care only.
• \. Patients who cannot obtain effective efficacy assessment data.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: May 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

CN (1)