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

NCT04952818 | Completed

• 1 other identifier: M2019460
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Spinal Tumor

Keywords

giant cell tumor of bone; radiomics; recurrence; spine tumor

Outcome Measures

Primary Outcomes (3)

• RANK/RANKL

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

  2020

• VEGF

  Grade:low;high(Vascular Endothelial Growth Factors)

  2020

• p53

  Grade:low;high(Tumor Suppressor Protein)

  2020

Secondary Outcomes (1)

• Recurrence

  2020

Study Arms (2)

RANK/RANKL low expression

Diagnostic Test: RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)

RANK/RANKL high expression

Diagnostic Test: RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)

Interventions

RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand) DIAGNOSTIC_TEST

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).

RANK/RANKL high expression; RANK/RANKL low expression

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with spinal GCTB

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University third hospital

Beijing, Please Select An Option Below, 100089, China

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms; Giant Cell Tumor of Bone; Recurrence

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Bone Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ning Lang

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 7, 2021
• Study Start: January 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 7, 2021

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)