NCT05167630

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

8.3 years

First QC Date

December 12, 2021

Last Update Submit

December 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    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

Interventions

prognostic marker

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhengzhou university

Zhengzhou, Henan, 450052, China

RECRUITING

Central Study Contacts

Mingzhi Zhang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 12, 2021

First Posted

December 22, 2021

Study Start

September 1, 2013

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

December 22, 2021

Record last verified: 2021-12

Locations