ClinicalTrials.gg
CompletedNCT04952818Updated Jul 7, 2021

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

An observational study in Spinal Tumor, sponsored by Peking University Third Hospital. Completed at 1 site in China. Open to participants aged 1 Year to 100 Years. Per ClinicalTrials.gov, last updated 2021-07-07.

Sponsored by Peking University Third Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
1 Year to 100 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Spinal Tumor

Keywords

  • giant cell tumor of bone
  • radiomics
  • recurrence
  • spine tumor
03

In context

Spinal Cord Neoplasms

105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.

This study's enrollment of 100 is below the median of 150 across 31 observational studies indexed under Spinal Cord Neoplasms.

Browse Spinal Cord Neoplasms studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with spinal GCTB

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testRANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β 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).

06

What researchers measure

Primary outcomes

  1. RANK/RANKL

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

    Time frame: 2020

  2. VEGF

    Grade:low;high(Vascular Endothelial Growth Factors)

    Time frame: 2020

  3. p53

    Grade:low;high(Tumor Suppressor Protein)

    Time frame: 2020

Secondary outcomes

  1. Recurrence

    recurrence group/non-recurrence group

    Time frame: 2020

07

Study locations

1 site
  • Peking University third hospital
    Beijing, Please Select An Option Below 100089, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04952818
Responsible party
Sponsor
First posted
Jul 7, 2021
Start date
Jan 1, 2020
Primary completion
Mar 1, 2020
Completion
Mar 1, 2020
Last update
Jul 7, 2021

Study contacts

Ning Lang
study chair · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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