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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06914700
Study groupRoleWhat they receive
PCNSLThe postoperative pathological result is PCNSL
GliomaThe postoperative pathological result is Glioma
GBMThe postoperative pathological result is GBM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted6 Apr 2025
  2. Study start1 Sep 2016
  3. Primary completion1 Aug 2024
  4. Study completion1 Dec 2024

Resources

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)
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

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.

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