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

Sponsor
Ruijin Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05907447
Collaborator
Nanfang Hospital of Southern Medical University (Other), Fujian Medical University Union Hospital (Other), Peking University Third Hospital (Other), Peking University People's Hospital (Other), Peking Union Medical College Hospital (Other), Beijing Hospital (Other), The Second Affiliated Hospital of Dalian Medical University (Other), The First Affiliated Hospital of Guangzhou Medical University (Other), Henan Provincial People's Hospital (Other), Hunan Cancer Hospital (Other), Henan Cancer Hospital (Other), The First Hospital of Jilin University (Other), Wuhan Union Hospital, China (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), Affiliated Hospital of Nantong University (Other), The First Affiliated Hospital of Xiamen University (Other), Shandong Provincial Hospital (Other), Shanxi Province Cancer Hospital (Other), RenJi Hospital (Other), Beijing Friendship Hospital (Other), West China Hospital (Other), The First Affiliated Hospital of Soochow University (Other), Tongji Hospital (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), Sun Yat-sen University (Other), Chongqing University Cancer Hospital (Other), Anhui Provincial Cancer Hospital (Other), The General Hospital of Northern Theater Command (Other), Qilu Hospital of Shandong University (Other), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), The Affiliated Hospital Of Guizhou Medical University (Other), Wuhan TongJi Hospital (Other), General Hospital of Ningxia Medical University (Other), The First Affiliated Hospital of Nanchang University (Other), The First Affiliated Hospital with Nanjing Medical University (Other), Anshan Central Hospital (Other), Hainan Cancer Hospital (Other), Fifth Affiliated Hospital of Guangzhou Medical University (Other), The First Affiliated Hospital of Anhui Medical University (Other), The Affiliated Hospital of Xuzhou Medical University (Other), First Affiliated Hospital of Harbin Medical University (Other), Zhujiang Hospital (Other)
10,000
1
15
664.6

Study Details

Study Description

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 Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Study on Extranodal Lymphoma or Lymphoma of Rare Pathological Types
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Weili, Prof., Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT05907447
Other Study ID Numbers:
  • EXPECT-01
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhao Weili, Prof., Ruijin Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023