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

June 15, 2023 updated by: Zhao Weili, Ruijin Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
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.
Baseline up to data cut-off (up to approximately 1 year)
Progression Free Survival (PFS)
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.
Baseline up to data cut-off (up to approximately 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to data cut-off (up to approximately 1 year)
Biological characteristics form
Time Frame: 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.
Baseline up to data cut-off (up to approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPECT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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