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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05907447
• Other study ID #: EXPECT-01
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2023
• Source: Ruijin Hospital
• Contact: Weili Prof. Zhao
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: October 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Diffuse Large B Cell Lymphoma
• Intravascular Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Marginal Zone Lymphoma
• Mucosa-Associated Lymphoid Tissue Lymphoma

Intervention

Other:
• No interventions need to be specified for this study
No interventions need to be specified for this study

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (43)

Lead Sponsor

Collaborator

Ruijin Hospital

Affiliated Hospital of Nantong University, Anhui Provincial Cancer Hospital, Anshan Central Hospital, Beijing Friendship Hospital, Beijing Hospital, Chongqing University Cancer Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Harbin Medical University, Fujian Medical University Union Hospital, General Hospital of Ningxia Medical University, Hainan Cancer Hospital, Henan Cancer Hospital, Henan Provincial People's Hospital, Hunan Cancer Hospital, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, Peking University People's Hospital, Peking University Third Hospital, Qilu Hospital of Shandong University, RenJi Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shandong Provincial Hospital, Shanxi Province Cancer Hospital, Sun Yat-sen University, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital with Nanjing Medical University, The First Hospital of Jilin University, The General Hospital of Northern Theater Command, The Second Affiliated Hospital of Dalian Medical University, Tongji Hospital, West China Hospital, Wuhan TongJi Hospital, Wuhan Union Hospital, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.	Baseline up to data cut-off (up to approximately 1 year)
Primary	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.	Baseline up to data cut-off (up to approximately 1 year)
Secondary	Clinical characteristics form	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.	Baseline up to data cut-off (up to approximately 1 year)
Secondary	Biological characteristics form	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.	Baseline up to data cut-off (up to approximately 1 year)