Spinal InfectionNCT06172153
Diagnostic Efficacy of Metagenomic Next-generation Sequencing in Patients With Spinal Infections: A Retrospective Study
An observational study of Spinal Infection and Diagnositic Efficacy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Comparing the diagnostic efficacy between traditional laboratory methods and second-generation high-throughput sequencing in patients suspected of spinal infections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Infection, Diagnositic Efficacy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: "The patients suspected of spinal infections were admitted to the Orthopedic Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University."
Who may be able to join
- "Patients suspected of spinal infections, as per the American Infectious Diseases Society's 2015 criteria for primary vertebral osteomyelitis, were identified based on their clinical symptoms, laboratory tests, and imaging examinations. All cases included in the study underwent laboratory examinations, histopathological examinations, and second-generation high-throughput sequencing (metagenomic sequencing)."
Who cannot join
- "The absence of laboratory examinations, histopathological examinations, and results from second-generation high-throughput sequencing (metagenomic sequencing)."
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen memorial hospital
Guangzhou, Guangdong, 510000
Chunhai Li, MD, 18602079796, lichhai@mail.sysu.edu.cn
hanwen cheng, Master, 19541080926, chenghw3@mail2.sysu.edu.cn
About this study
Comparing the diagnostic efficacy between traditional laboratory methods and second-generation high-throughput sequencing in patients suspected of spinal infections.
- Conditions
- Spinal Infection, Diagnositic Efficacy
- Being tested
- No interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Sun Yat-sen memorial hospital | Patients who were suspected of Spinal infection. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnositic efficacy
Sensitivity, Specificity
Measured: 1 year
The diagnositic efficacy
Positive Predictive Value, Negative Predictive Value
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jun 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InfectionStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunhai Li, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172153
- Sponsor's protocol ID
- SYSKY-2023-1095-01
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Efficacy of Metagenomic Next-generation Sequencing in Patients With Spinal Infections: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06172153
- Acronym / sponsor ID
- SYSKY-2023-1095-01
- Conditions
- Spinal Infection, Diagnositic Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 15 Dec 2023 (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.
Comparing the diagnostic efficacy between traditional laboratory methods and second-generation high-throughput sequencing in patients suspected of spinal infections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-sen memorial hospital | – | Other: No interventionsPatients who were suspected of Spinal infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- "The patients suspected of spinal infections were admitted to the Orthopedic Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University."
Key inclusion criteria (1 listed)
- "Patients suspected of spinal infections, as per the American Infectious Diseases Society's 2015 criteria for primary vertebral osteomyelitis, were identified based on their clinical symptoms, laboratory tests, and imaging examinations. All cases included in the study underwent laboratory examinations, histopathological examinations, and second-generation high-throughput sequencing (metagenomic sequencing)."
Key exclusion criteria (1 listed)
- "The absence of laboratory examinations, histopathological examinations, and results from second-generation high-throughput sequencing (metagenomic sequencing)."
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 |
|---|---|---|
| No interventionsNo intervention | Other | Sun Yat-sen memorial hospital |
Primary outcome
The diagnositic efficacy
Time frame: 1 year
Sensitivity, Specificity
The diagnositic efficacy
Time frame: 1 year
Positive Predictive Value, Negative Predictive Value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- 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.
Chunhai Li, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Infection and Diagnositic Efficacy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunhai Li, MD (18602079796, lichhai@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnositic efficacy (time frame: 1 year). The study lists 2 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 15 Dec 2023.