Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone

March 30, 2024 updated by: Changye Zou

Treatment of Giant Cell Bone Tumor With Purerin: New Insights From Network Pharmacology, Bioinformatics Analysis, and Experimental Verification

Based on network pharmacology analysis, this study aims to explore the potential therapeutic targets and molecular mechanisms of puerarin on giant cell tumor of bone (GCTB) genes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The giant cell tumor of bone's pathological genes were discovered from DisGeNET and GeneCards databases. The therapeutic genes of puerarin were gathered from Swiss Target Prediction, CTD(Comparative Toxicogenomics Database), PharmMapper, and TCMSP databases (Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform). Cytoscape software was used with the MCODE algorithm to calculate key potential therapeutic targets of puerarin against GCTB. The bulk RNA-seq datasets (GSE102193) were used to identify differential expression of potential therapeutic genes. The sc RNA-seq (GSE168664) was utilized to determine the expression distribution of different cell clusters. Essential targets of puerarin against GCTB underwent function and pathway enrichment assays to elucidate biological processes and signaling pathways. Furthermore, the investigators conducted a comparison to determine if the primary biological processes and pathways following denosumab treatment exhibit resemblances to the potential mechanisms of puerarin action. Molecular docking and dynamics simulation were conducted to evaluate interactions between selected potential therapeutic targets and puerarin. Immunohistochemical (IHC) and immunofluorescence (IF) staining were performed to identify the expression of crucial markers in human GCTB tissue. Expression levels of pivotal genes in primary BMSC cells and primary GCTB cells and their alteration following puerarin treatment in primary GCTB cells were evaluated.The significance of differences between groups was estimated by the Student t-test or Wilcoxon test. In all the statistical analyses, data with two-tailed p < 0.05 were considered statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 518010
        • Churong Yan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

1st hospital of SYSU provides diagnosis and treatment that meets the inclusion criteria.

Description

Inclusion Criteria:

  1. Diagnosed as a patient with giant cell tumor of bone;
  2. Performing surgical treatment in 1st hospital of SYSU;
  3. Having complete clinical registration information;
  4. Preserve surgical or puncture specimens;

Exclusion Criteria:

  1. Non bone giant cell tumor patients;
  2. No surgical treatment was performed;
  3. Incomplete clinical information registration;
  4. No preserved surgical or puncture specimens.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
P27 expression groups
12 immunohistochemical sections were scored under the microscope (staining intensity scores: negative 0 points, weak 1 point, medium 2 points, strong 3 points; positive cell frequency scores: less than 5% 0 points, 2-25% 1 point, 26-50% 2 points, 51-75% 3 points, greater than 75% 4 points).
Genetic: gene expression levels
12 immunohistochemical sections were scored under the microscope (staining intensity scores: negative 0 points, weak 1 point, medium 2 points, strong 3 points; positive cell frequency scores: less than 5% 0 points, 2-25% 1 point, 26-50% 2 points, 51-75% 3 points, greater than 75% 4 points).
ESR1 expression groups
12 immunohistochemical sections were scored under the microscope (staining intensity scores: negative 0 points, weak 1 point, medium 2 points, strong 3 points; positive cell frequency scores: less than 5% 0 points, 2-25% 1 point, 26-50% 2 points, 51-75% 3 points, greater than 75% 4 points).
Genetic: gene expression levels
12 immunohistochemical sections were scored under the microscope (staining intensity scores: negative 0 points, weak 1 point, medium 2 points, strong 3 points; positive cell frequency scores: less than 5% 0 points, 2-25% 1 point, 26-50% 2 points, 51-75% 3 points, greater than 75% 4 points).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
P27 expression levels
Time Frame: 2023-05-18 - 2023-08-31
12 immunohistochemical sections were scored under the microscope (staining intensity scores: negative 0 points, weak 1 point, medium 2 points, strong 3 points; positive cell frequency scores: less than 5% 0 points, 2-25% 1 point, 26-50% 2 points, 51-75% 3 points, greater than 75% 4 points).
2023-05-18 - 2023-08-31
ESR1 expression levels
Time Frame: 2023-05-18 - 2023-08-31
12 immunohistochemical sections were scored under the microscope (staining intensity scores: negative 0 points, weak 1 point, medium 2 points, strong 3 points; positive cell frequency scores: less than 5% 0 points, 2-25% 1 point, 26-50% 2 points, 51-75% 3 points, greater than 75% 4 points).
2023-05-18 - 2023-08-31

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changye Zou

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Changye Zou, MD, First Affiliated Hospital, Sun Yat-Sen 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ChangyeZou

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.

IPD Sharing Time Frame

SCI online. The datasets are available from the corresponding author on reasonable request.

IPD Sharing Access Criteria

The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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