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NCT Number: NCT04952818

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

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.

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Key information

Conditions

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

Age range

1 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University third hospital

Beijing, Please Select An Option Below, 100089, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. RANK/RANKL

    Time frame: 2020

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

  2. VEGF

    Time frame: 2020

    Grade:low;high(Vascular Endothelial Growth Factors)

  3. p53

    Time frame: 2020

    Grade:low;high(Tumor Suppressor Protein)

Secondary outcomes

  1. Recurrence

    Time frame: 2020

    recurrence group/non-recurrence group

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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