Bone TumorNCT04955522
Multimodal Imaging Analysis of Spinal Tumors
An observational study of Bone Tumor, run by Peking University Third Hospital at 1 site in China.
Trial summary
In this study, we retrospectively analyzed the imaging data of spinal tumors to find out more imaging features of spinal tumors, in order to provide more accurate reference for the diagnosis of spinal tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Tumor
- What is being tested?
- radiomics
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Dec 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Spinal tumor patients in Peking University Third Hospital from January 2006 to October 2019
Who may be able to join
- Complete and accurate clinical and pathological data are available；Imaging examination was performed in our hospital
Who cannot join
- Patients with missing image data and unclear image
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we retrospectively analyzed the imaging data of spinal tumors to find out more imaging features of spinal tumors, in order to provide more accurate reference for the diagnosis of spinal tumors.
Read the detailed description
Bone tumors account for 1-2% of total body tumors, and spinal tumors only account for 6.5% of total body tumors. Because of the low incidence rate, the number of patients and the attention in this field are far lower than other tumors, so far, all the researches on spinal tumors are relatively lacking. Because the diagnosis of bone tumor needs the combination of clinical, imaging and pathological to make a more accurate diagnosis, so the imaging diagnosis of spinal tumor is very important. In this study, through retrospective analysis of a variety of imaging data of patients with spinal tumor, measurement and recording of spinal tumor image related parameters, and statistical analysis, in order to find out more imaging characteristics of patients with spinal tumor, more accurate diagnosis of lesions, and provide more help for clinical decision-making.
- Conditions
- Bone Tumor
- Being tested
- radiomics
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiomicsDiagnostic test
Differential diagnosis of spinal myeloma and metastases by radiomics
| Study group | Role | What they receive |
|---|---|---|
| metastases | patients with spinal metastases Receives: Diagnostic Test: radiomics | |
| multiple myeloma | patients with spinal multiple myeloma |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiomics features
1409 radiomics features can be extracted from the images. Objective to search for the radiomics index which is helpful to the diagnosis of tumor.
Measured: 2020.12.1-2020.12.25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Dec 2019
- Primary completion15 Dec 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955522
- Sponsor's protocol ID
- M2019501
- Status last verified
- Dec 2019
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging Analysis of Spinal Tumors
- ClinicalTrials.gov ID
- NCT04955522
- Acronym / sponsor ID
- M2019501
- Conditions
- Bone Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 8 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.
In this study, we retrospectively analyzed the imaging data of spinal tumors to find out more imaging features of spinal tumors, in order to provide more accurate reference for the diagnosis of spinal tumors.
Detailed description
Bone tumors account for 1-2% of total body tumors, and spinal tumors only account for 6.5% of total body tumors. Because of the low incidence rate, the number of patients and the attention in this field are far lower than other tumors, so far, all the researches on spinal tumors are relatively lacking. Because the diagnosis of bone tumor needs the combination of clinical, imaging and pathological to make a more accurate diagnosis, so the imaging diagnosis of spinal tumor is very important. In this study, through retrospective analysis of a variety of imaging data of patients with spinal tumor, measurement and recording of spinal tumor image related parameters, and statistical analysis, in order to find out more imaging characteristics of patients with spinal tumor, more accurate diagnosis of lesions, and provide more help for clinical decision-making.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metastases | – | Diagnostic Test: radiomicspatients with spinal metastases |
| multiple myeloma | – | –patients with spinal multiple myeloma |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Spinal tumor patients in Peking University Third Hospital from January 2006 to October 2019
Key inclusion criteria (1 listed)
- Complete and accurate clinical and pathological data are available；Imaging examination was performed in our hospital
Key exclusion criteria (1 listed)
- Patients with missing image data and unclear image
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 |
|---|---|---|
| radiomicsDifferential diagnosis of spinal myeloma and metastases by radiomics | Diagnostic test | metastases |
Primary outcome
radiomics features
Time frame: 2020.12.1-2020.12.25
1409 radiomics features can be extracted from the images. Objective to search for the radiomics index which is helpful to the diagnosis of tumor.
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 8 Jul 2021.
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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.
Huishu Yuan 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 Bone 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 8 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?
radiomics features (time frame: 2020.12.1-2020.12.25). 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 8 Jul 2021.