Clinical trial NCT06331104: Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone
Official title: Treatment of Giant Cell Bone Tumor With Purerin: New Insights From Network Pharmacology, Bioinformatics Analysis, and Experimental Verification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Tumors
Keywords: Giant Cell Tumors
Puerarin
Treatment
Traditional Chinese medicine
Network Pharmacology
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1st hospital of SYSU provides diagnosis and treatment that meets the inclusion criteria.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: P27 expression levels
timeFrame: 2023-05-18 - 2023-08-31
measure: ESR1 expression levels
timeFrame: 2023-05-18 - 2023-08-31
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Churong Yan
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Changye Zou, MD
role: PRINCIPAL_INVESTIGATOR
References: