Prognosis Factors in Patients With Primary Central Nervous System Lymphoma

December 12, 2021 updated by: Mingzhi Zhang, Zhengzhou University
Primary central nervous system lymphoma (PCNSL) is a rare extranodal non-hodgkin's lymphoma confined to the central nervous system. It accounts for about 4% of all intracranial tumors and 4% to 6% of all non-Hodgkin's lymphomas . Among them, the most common type is diffuse large B cell lymphoma (DLBCL), accounting for about 95% of all cases. High dose methotrexate (HD-MTX) based chemotherapy can improve the prognosis of patients, but only 30% to 40% of patients can achieve sustained remission, and the overall prognosis is very poor[4, 6]. Currently, the International Extranodal Lymphoma Study Group (IESLG) prognostic scoring system and the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic index are widely used to evaluate the prognosis in patients with PCNSL. However, IESLG model has some limitations such as the relatively small number of patients and short follow-up period. MSKCC model may have an inherent selection bias because retrospective data were collected from a single large institution. Therefore, there is a urgent need to identify novel indicators for prognosis evaluation and risk stratification in PCNSL patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

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 Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Zhengzhou University
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical data of PCNSL patients were collected retrospectively, such as sex, age, physical state (ECOG score), cell source classification, number of lesions, whether the lesions involved deep structure, etc. The data of laboratory examination include the protein content in cerebrospinal fluid, lactate dehydrogenase (LDH), β2- macroglobulin (β2-MG), IESLG score, ALC and Ki-67.

Description

Inclusion Criteria:

(i)The pathological biopsy and immunohistochemistry diagnosis were PCNSL according to WHO diagnostic criteria for PCNSL in 2016. (ii) No treatment has been received. (iii)There were no diseases with malignant tumor, serious infection, other blood system diseases, immune system diseases and other conditions which may have great influence on peripheral blood lymphocyte count. (iv) The clinical data were complete.

Exclusion Criteria:

-

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
Time Frame: from September 1, 2013 to June 1, 2020
from the date of diagnosis to death from any cause or to the date of last follow-up
from September 1, 2013 to June 1, 2020

Collaborators and Investigators

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

Sponsor

Zhengzhou 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 (Actual)

September 1, 2013

Primary Completion (Anticipated)

December 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

December 12, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • hnslblzlzx20211001

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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