Spinal TumorNCT04952818
The Value of Preoperative Diagnosis and Prognostic Prediction Based on Radiomics of Giant Cell Tumor of Spine
An observational study of Spinal Tumor, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Spinal Tumor
- What is being tested?
- RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with spinal GCTB
Who may be able to join
- Patients diagnosed with spinal GCTB who underwent surgical resection or biopsy without preoperative chemotherapy or radiotherapy were included in this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University third hospital
Beijing, Please Select An Option Below, 100089
About this study
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.
- 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.
- 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.
- Conditions
- Spinal Tumor
- Being tested
- RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)
- Keywords
- giant cell tumor of bone, radiomics, recurrence, spine tumor
- Medical subject headings
- Spinal Cord Neoplasms, Giant Cell Tumor of Bone, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| RANK/RANKL low expression | Not described Receives: 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 | Not described Receives: Diagnostic Test: RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RANK/RANKL
Grade:low;high(Receptor Activator of Nuclear factor Kappa-Β/Ligand)
Measured: 2020
VEGF
Grade:low;high(Vascular Endothelial Growth Factors)
Measured: 2020
p53
Grade:low;high(Tumor Suppressor Protein)
Measured: 2020
Secondary outcomes (1)
Recurrence
recurrence group/non-recurrence group
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Lang, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952818
- Sponsor's protocol ID
- M2019460
- Status last verified
- Aug 2019
- First submitted
- 28 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04952818
- Acronym / sponsor ID
- M2019460
- Conditions
- Spinal Tumor
- Keywords
- giant cell tumor of bone, radiomics, recurrence, spine tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with spinal GCTB
Key inclusion criteria (1 listed)
- Patients diagnosed with spinal GCTB who underwent surgical resection or biopsy without preoperative chemotherapy or radiotherapy were included in this study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | RANK/RANKL high expression, RANK/RANKL low expression |
Primary outcome
RANK/RANKL
Time frame: 2020
Grade:low;high(Receptor Activator of Nuclear factor Kappa-Β/Ligand)
VEGF
Time frame: 2020
Grade:low;high(Vascular Endothelial Growth Factors)
p53
Time frame: 2020
Grade:low;high(Tumor Suppressor Protein)
1 secondary outcome
Recurrence
Time frame: 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Lang study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Tumor, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RANK/RANKL (time frame: 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.