PCNSLNCT05167630
Prognosis Factors in Patients With Primary Central Nervous System Lymphoma
An observational study of PCNSL and Survival Analysis, run by Zhengzhou University at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PCNSL, Survival Analysis
- What is being tested?
- prognostic marker
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2013to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhengzhou university
Zhengzhou, Henan, 450052
Mingzhi Zhang, Dr, 8637166295562, mingzhi_zhang1@163.com
About this study
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.
- Conditions
- PCNSL, Survival Analysis
- Being tested
- prognostic marker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prognostic markerOther
prognostic marker
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
from the date of diagnosis to death from any cause or to the date of last follow-up
Measured: from September 1, 2013 to June 1, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Sep 2013
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCNSLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingzhi Zhang, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167630
- Sponsor's protocol ID
- hnslblzlzx20211001
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Factors in Patients With Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT05167630
- Acronym / sponsor ID
- hnslblzlzx20211001
- Conditions
- PCNSL, Survival Analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prognostic markerprognostic marker | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCNSL and Survival Analysis, run by Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingzhi Zhang, Doctor (+8637166295561, mingzhi_zhang1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: from September 1, 2013 to June 1, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.