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Clinical Trials/NCT04952818
NCT04952818
Completed
Not Applicable

Radiomics Based on Preoperative Imaging of Giant Cell Tumor of the Spine to Predict the Early Recurrence and Survival of Giant Cell Tumor of the Spine After Surgery, and the Expression Levels of P53, VEGF, RANK, RANKL and Other Prognostic-related Molecular Markers.

Peking University Third Hospital1 site in 1 country100 target enrollmentJanuary 1, 2020
ConditionsSpinal Tumor

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Tumor
Sponsor
Peking University Third Hospital
Enrollment
100
Locations
1
Primary Endpoint
RANK/RANKL
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

  1. Exploit CT (plain scan), enhanced CT and fMRI based radiomic biomarkers, explore their correlation with the prognostic molecular markers of spinal GCTB(p53/vegf/rank/rankl...), and help accurate diagnosis of GCTB.
  2. Exploring a new method of preoperative risk stratification for spinal GCTB, and establishing radiomic model combined with clinical features. Exploring the GCTB biological behavior prediction model and the prognosis prediction of GCTB.

Detailed Description

This study intends to conduct a systematic review of patients with spinal GCTB who have undergone standardized imaging (CT or MRI) in our hospital since 2006 to obtain case samples, conduct standardized clinical and imaging data extraction and analysis, and fully integrate histopathology and clinical follow-up results. To preliminarily explore the value of postoperative imaging-based radiomics markers in the preoperative precise diagnosis of spinal GCTB, risk stratification and prediction of tumor biological behavior.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
March 1, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with spinal GCTB who underwent surgical resection or biopsy without preoperative chemotherapy or radiotherapy were included in this study.

Exclusion Criteria

  • i) The CT scan was performed more than 1 week before surgery ii) Poor image quality. Such as surrounding structure artifacts; iii) The remaining tumor tissue in the postoperative paraffin specimen is too little to be used for reanalysis; iv) Cases with negative H3F3A (H3 histone, family 3A) staining were excluded; v) Incomplete clinical information.

Outcomes

Primary Outcomes

RANK/RANKL

Time Frame: 2020

Grade:low;high(Receptor Activator of Nuclear factor Kappa-Β/Ligand)

VEGF

Time Frame: 2020

Grade:low;high(Vascular Endothelial Growth Factors)

p53

Time Frame: 2020

Grade:low;high(Tumor Suppressor Protein)

Secondary Outcomes

  • Recurrence(2020)

Study Sites (1)

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