A Retrospective Study on Extranodal Lymphoma or Lymphoma of Rare Pathological Types

Not yet recruiting

• Conditions: NK/T-Cell Lymphoma, Nasal and Nasal-Type; Intravascular Large B-Cell Lymphoma; Extranodal Lymphoma; Mucosa-Associated Lymphoid Tissue Lymphoma; Angioimmunoblastic T-cell Lymphoma; Lymphoma; Diffuse Large B Cell Lymphoma; Anaplastic Large Cell Lymphoma; Marginal Zone Lymphoma

• Registration Number: NCT05907447
• Lead Sponsor: Ruijin Hospital

Brief Summary

The aim of this study is to retrospectively collect clinical information on patients with extranodal or rare lymphomas, and to explore the best treatment strategy for these lymphomas in the real-world population.

Detailed Description

Lymphoma is a highly common malignant tumor in Asia. For specific extra-abdominal sites or rare pathological subtypes of lymphoma, traditional chemotherapy protocols often cannot provide satisfactory results for patients. This study aims to retrospectively collect clinical information on patients with extranodal lymphoma or rare pathological subtype lymphoma, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the best treatment strategy for these lymphomas in the real-world population.

Study Timeline

• Study First Submitted: 2023-05-01
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Study Start: 2023-07-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1. Age ≥ 18 years (including 18 years old).
2. Patients newly diagnosed with non-Hodgkin lymphoma with extranodal involvement, whether it is primary, secondary, or cannot be determined; Or patients newly diagnosed with non-Hodgkin lymphoma of rare pathological types, including IVLBCL, SMZL, ALCL, AITL, MALTL.
3. Patients who have received systematic clinical treatment.
4. Patients with measurable lesions, at least containing one effective evaluation of efficacy.

Exclusion Criteria

1. Patients who only receive supportive treatment.
2. Patients who cannot obtain effective evaluation data of efficacy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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.
Progression Free Survival (PFS)	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 Outcome Measures

Name	Time	Method
Clinical characteristics form	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.
Biological characteristics form	Baseline up to data cut-off (up to approximately 1 year)	Biological characteristics from data filled into registry forms by physicians and data managers, such as immunohistochemical differences and genetic mutation characteristics of non-hodgkin´s lymphomas.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China