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

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ClinicalTrials.gov Identifier: NCT04952818
Recruitment Status : Completed
First Posted : July 7, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

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.

Condition or disease Intervention/treatment
Spinal Tumor Diagnostic Test: RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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.
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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 Diagnostic Test: RANK/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).




Primary Outcome Measures :
  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 Outcome Measures :
  1. Recurrence [ Time Frame: 2020 ]
    recurrence group/non-recurrence group



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with spinal GCTB
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04952818


Locations
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China, Please Select An Option Below
Peking University third hospital
Beijing, Please Select An Option Below, China, 100089
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Chair: Ning Lang Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04952818    
Other Study ID Numbers: M2019460
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
giant cell tumor of bone
radiomics
recurrence
spine tumor
Additional relevant MeSH terms:
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Giant Cell Tumors
Spinal Cord Neoplasms
Spinal Neoplasms
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases