Central Malignant TumorsPCNSL,GLIOMANCT06914700
A Nomogram for Predicting the Diagnosis of Central Malignant Tumors Based on Preoperative Clinical Characteristics and Laboratory Indicators:
An observational study of Central Malignant Tumors and PCNSL, run by Guangdong Provincial People's Hospital.
Trial summary
The purpose of this study is to develop a nomogram to predict the diagnostic probability of preoperative central lymphoma and glioma, as well as the diagnostic probability of glioblastoma and non glioblastoma in central malignant tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Malignant Tumors, PCNSL, Glioma
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Dec 2024
- 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: The first postoperative pathological result suggests patients with PCNSL or GLioma
Who may be able to join
- Patients who underwent surgical treatment and were diagnosed with PNCSL or glioma after surgery;
Who cannot join
- Patients who have not undergone their first surgery
About this study
Official title: Neurosurgery Department of Guangdong Provincial People's Hospital
The purpose of this study is to develop a nomogram to predict the diagnostic probability of preoperative central lymphoma and glioma, as well as the diagnostic probability of glioblastoma and non glioblastoma in central malignant tumors. The author retrospectively analyzed patients with central lymphoma and glioma who received treatment in the neurosurgery department of Guangdong Provincial People's Hospital from 2016 to 2024. Eligible patients were randomly divided into training and validation sets in a 7:3 ratio. By integrating the least absolute shrinkage and selection operator [LASSO] and multivariate logistic regression analysis, the key variables for establishing a nomogram were identified. Moreover, seven models including logistic regression, decision tree, random forest, support vector machine (SVM), neural network, XGBoost, and lightGBM were used to calculate the area under the receiver operating characteristic curve (AUC)
Read the detailed description
this study aimed to develop and validate a novel diagnostic model, based on a large cohort of clinical data, for accurate differentiation between PCNSL and glioma, and GBM and non-GBM.
the Ethics Review Committee of Guangdong Provincial People's Hospital granted ethical approval for this study (KY-Z-2022-231-01). This retrospective cohort study included 127 patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma (PCNSL) and 586 patients with newly diagnosed glioma, treated at the Department of Neurosurgery, Guangdong Provincial People's Hospital, between 2016 and 2024. Patients included in this study met the following criteria: (1) HIV-seronegative status; (2) no history of immunosuppression or organ transplantation; (3) availability of all clinical indicators prior to the first surgery; (4) sufficient clinical and data availability. All participants were informed of the study's purpose and provided signed informed consent prior to participation, in accordance with the principles outlined in the Declaration of Helsinki.
Basic demographic and clinical data were collected prior to initial diagnosis and first surgical treatment. Demographic data included age and sex, while clinical data encompassed peripheral white blood cell count (WBC), neutrophil-to-lymphocyte ratio (NEUT1), lymphocyte ratio (LYMPH1), neutrophil count (NEUT), lymphocyte count (LYMPH), monocyte count (MONO), international normalized ratio (INR), prothrombin time (PT) and albumin.
Patients were randomly assigned to training and validation cohorts in a 7:3 ratio for both diagnostic models, comprising 713 and 586 patients, respectively. No significant differences in demographic or clinical characteristics were observed between the training and validation sets. To identify potential predictors, LASSO regression analysis was performed on the training set, effectively eliminating several irrelevant or multicollinear independent variables to reduce dimensionality. Subsequently, multivariable logistic regression analysis was employed to determine the characteristic variables. Finally, a nomogram was constructed based on the training set and validated in the validation set.
The predictive performance of the model was assessed and validated using machine learning and deep learning techniques. Model discrimination was evaluated using receiver operating characteristic (ROC) curve analysis. Decision curve analysis (DCA) was employed to assess the model's net benefit and clinical utility.
Categorical variables were described using frequencies and percentages. Chi-squared tests or t-tests were used to compare data between the two cohorts. A LASSO regression model was applied to mitigate potential multicollinearity. All variables with complete data in the training cohort were included in the LASSO regression analysis using the "glmnet" package in R software. The model achieved optimal performance at Lambda.min, thus identifying candidate variables. Subsequently, multivariable Cox proportional hazards regression analysis was performed to identify independent predictors associated with the binary outcome. These factors were then integrated to construct a nomogram prediction model using the "rms" package in R software. Seven additional models-logistic regression, decision tree, random forest, support vector machine (SVM), neural network, XGBoost, and LightGBM-were constructed using the "caret" package, and decision curves were generated using the "rmda" package. All statistical analyses were performed using R software version 4.4.2, and a p-value < 0.05 was considered statistically significant.
- Conditions
- Central Malignant Tumors, PCNSL, Glioma, GBM
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCNSL | The postoperative pathological result is PCNSL | |
| Glioma | The postoperative pathological result is Glioma | |
| GBM | The postoperative pathological result is GBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependent Receiver Operating Characteristic (ROC) curve
Measured: The most recent blood test result before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Sep 2016
- Primary completion1 Aug 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhoudong, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914700
- Sponsor's protocol ID
- GDPH-PG
- Acronym
- PCNSL,GLIOMA
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurosurgery Department of Guangdong Provincial People's Hospital
- ClinicalTrials.gov ID
- NCT06914700
- Acronym / sponsor ID
- PCNSL,GLIOMA / GDPH-PG
- Conditions
- Central Malignant Tumors, PCNSL, Glioma, GBM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 6 Apr 2025 (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.
The purpose of this study is to develop a nomogram to predict the diagnostic probability of preoperative central lymphoma and glioma, as well as the diagnostic probability of glioblastoma and non glioblastoma in central malignant tumors. The author retrospectively analyzed patients with central lymphoma and glioma who received treatment in the neurosurgery department of Guangdong Provincial People's Hospital from 2016 to 2024. Eligible patients were randomly divided into training and validation sets in a 7:3 ratio. By integrating the least absolute shrinkage and selection operator [LASSO] and multivariate logistic regression analysis, the key variables for establishing a nomogram were identified. Moreover, seven models including logistic regression, decision tree, random forest, support vector machine (SVM), neural network, XGBoost, and lightGBM were used to calculate the area under the receiver operating characteristic curve (AUC)
Detailed description
this study aimed to develop and validate a novel diagnostic model, based on a large cohort of clinical data, for accurate differentiation between PCNSL and glioma, and GBM and non-GBM.
the Ethics Review Committee of Guangdong Provincial People's Hospital granted ethical approval for this study (KY-Z-2022-231-01). This retrospective cohort study included 127 patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma (PCNSL) and 586 patients with newly diagnosed glioma, treated at the Department of Neurosurgery, Guangdong Provincial People's Hospital, between 2016 and 2024. Patients included in this study met the following criteria: (1) HIV-seronegative status; (2) no history of immunosuppression or organ transplantation; (3) availability of all clinical indicators prior to the first surgery; (4) sufficient clinical and data availability. All participants were informed of the study's purpose and provided signed informed consent prior to participation, in accordance with the principles outlined in the Declaration of Helsinki.
Basic demographic and clinical data were collected prior to initial diagnosis and first surgical treatment. Demographic data included age and sex, while clinical data encompassed peripheral white blood cell count (WBC), neutrophil-to-lymphocyte ratio (NEUT1), lymphocyte ratio (LYMPH1), neutrophil count (NEUT), lymphocyte count (LYMPH), monocyte count (MONO), international normalized ratio (INR), prothrombin time (PT) and albumin.
Patients were randomly assigned to training and validation cohorts in a 7:3 ratio for both diagnostic models, comprising 713 and 586 patients, respectively. No significant differences in demographic or clinical characteristics were observed between the training and validation sets. To identify potential predictors, LASSO regression analysis was performed on the training set, effectively eliminating several irrelevant or multicollinear independent variables to reduce dimensionality. Subsequently, multivariable logistic regression analysis was employed to determine the characteristic variables. Finally, a nomogram was constructed based on the training set and validated in the validation set.
The predictive performance of the model was assessed and validated using machine learning and deep learning techniques. Model discrimination was evaluated using receiver operating characteristic (ROC) curve analysis. Decision curve analysis (DCA) was employed to assess the model's net benefit and clinical utility.
Categorical variables were described using frequencies and percentages. Chi-squared tests or t-tests were used to compare data between the two cohorts. A LASSO regression model was applied to mitigate potential multicollinearity. All variables with complete data in the training cohort were included in the LASSO regression analysis using the "glmnet" package in R software. The model achieved optimal performance at Lambda.min, thus identifying candidate variables. Subsequently, multivariable Cox proportional hazards regression analysis was performed to identify independent predictors associated with the binary outcome. These factors were then integrated to construct a nomogram prediction model using the "rms" package in R software. Seven additional models-logistic regression, decision tree, random forest, support vector machine (SVM), neural network, XGBoost, and LightGBM-were constructed using the "caret" package, and decision curves were generated using the "rmda" package. All statistical analyses were performed using R software version 4.4.2, and a p-value < 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCNSL | – | –The postoperative pathological result is PCNSL |
| Glioma | – | –The postoperative pathological result is Glioma |
| GBM | – | –The postoperative pathological result is GBM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The first postoperative pathological result suggests patients with PCNSL or GLioma
Key inclusion criteria (1 listed)
- Patients who underwent surgical treatment and were diagnosed with PNCSL or glioma after surgery;
Key exclusion criteria (1 listed)
- Patients who have not undergone their first surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dependent Receiver Operating Characteristic (ROC) curve
Time frame: The most recent blood test result before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Malignant Tumors and PCNSL, run by Guangdong Provincial People's Hospital.
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: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependent Receiver Operating Characteristic (ROC) curve (time frame: The most recent blood test result before surgery). 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 9 Apr 2025.