A Real-World Study on Extranodal Lymphoma

August 23, 2024 updated by: Zhao Weili, Ruijin Hospital
The aim of this study is to prospectively collect clinical information on patients with extranodal lymphoma, and to explore the best therapeutic strategies in the real-world population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lymphoma is a common hematological malignancy. Many different pathologic types of lymphoma can originate in extranodal organs or be associated with extranodal organ involvement. For lymphoma with extranodal involvement, conventional regimens often cannot provide satisfactory results for patients. This study aims to prospectively collect clinical information on patients with extranodal DLBCL, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the the best therapeutic strategies in the real-world population.

Study Type

Observational

Enrollment (Estimated)

5000

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

  • Name: Weili Zhao, MD, PhD
  • Phone Number: 610707 +862164370045
  • Email: zwl_trial@163.com

Study Contact Backup

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement.

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.
  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
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
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)

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

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)

September 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPECT-02

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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