NCT06331104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2012

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

11.2 years

First QC Date

March 19, 2024

Last Update Submit

March 30, 2024

Conditions

Keywords

Giant Cell TumorsPuerarinTreatmentTraditional Chinese medicineNetwork Pharmacology

Outcome Measures

Primary Outcomes (2)

  • P27 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).

    2023-05-18 - 2023-08-31

  • ESR1 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).

    2023-05-18 - 2023-08-31

Study Arms (2)

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

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

Interventions

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 groupsP27 expression groups

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Churong Yan

Guangzhou, Guangdong, 518010, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Immunohistochemistry (IHC) and immunofluorescence staining were performed on the GCTB tissues of 145 patients (2 normal tissues, 51 recurrent, and 92 primary) from the First Affiliated Hospital of Sun Yat sen University to verify the differential expression and distribution of P27 and ESR1 in recurrent and primary lesions of giant cell tumor of bone patients. One patient's tissue was used for transcriptome sequencing to analyze changes in gene expression levels before and after routine treatment.

MeSH Terms

Conditions

Giant Cell Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Changye Zou, MD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Orthopedic Oncology, The First Affiliated Hospital of Sun Yat-sen University

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

June 14, 2012

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
SCI online. The datasets are available from the corresponding author on reasonable request.
Access Criteria
The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.

Locations