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Completed

NCT Number: NCT06549361

A Retrospective Study on Extranodal DLBCL

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

About this study

DLBCL is a highly common aggressive non-Hodgkin's lymphoma. For specific extranodal sites of DLBCL, traditional chemotherapy protocols often cannot provide satisfactory results for patients. The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, including the distribution of involved sites (such as central nervous system, testes, skin, breast, gastrointestinal tract, etc.), prognosis of diffuse large B-cell lymphoma with involvement of different extranodal sites, genetic mutation characteristics, correlation with molecular subtypes, impact of different treatment regimens on efficacy, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. ≥ 18 years (including 18 years).
  • 2. Pathologically diagnosed with diffuse large B-cell lymphoma according to the 2016 WHO classification, including non-specific types and various special subtypes.
  • 3. Newly diagnosed DLBCL with involvement of extranodal organs.
  • 4. Patients who have received clinical treatment for lymphoma.
  • 5.Patients with measurable lesions, including at least one effective efficacy assessment.

Exclusion criteria

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

Treatment and study plan

No interventions need to be specified for this study

Other

No interventions need to be specified for this study

Primary outcomes

  1. Overall Survival (OS)

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

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

  2. Progression Free Survival (PFS)

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

    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.

Secondary outcomes

  1. Clinical characteristics form

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

    Clinical characteristics from data filled into registry forms by physicians and data managers, including but not limited to values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number and location of extranodal localizations.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

The Retrospective Clinical Study of Extranodal Diffuse Large B-Cell Lymphoma

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

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.

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