The Value of Preoperative Diagnosis and Prognostic Prediction Based on Radiomics of Giant Cell Tumor of Spine

Spinal Tumor Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952818
• Other study ID #: M2019460
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2019
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Giant Cell Tumors
• Spinal Cord Neoplasms
• Spinal Neoplasms
• Spinal Tumor

Intervention

Diagnostic Test:
• RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-? /RANKL:Receptor Activator of Nuclear factor Kappa-? Ligand)
Immunohistochemical staining was performed using the following antibodies: anti-RANK antibody from Bioss Company (No.bs-2695R) and anti-RANKL antibody from Abcam (No.ab222215).

Locations

Country	Name	City	State
China	Peking University third hospital	Beijing	Please Select An Option Below

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RANK/RANKL	Grade:low;high(Receptor Activator of Nuclear factor Kappa-?/Ligand)	2020
Primary	VEGF	Grade:low;high(Vascular Endothelial Growth Factors)	2020
Primary	p53	Grade:low;high(Tumor Suppressor Protein)	2020
Secondary	Recurrence	recurrence group/non-recurrence group	2020