Bone TumoursAIorthoNCT04746001
Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection
An observational study of Bone Tumours and Bone Infection, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Tumours, Bone Infection, Prosthetic Joint Infection
- What is being tested?
- Genomic sequencing and Histological examination
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2021to 1 Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected orthopaedic infection (including prosthetic joint infection) or bone tumours
Who may be able to join
- Suspected infection of bone tumour and biopsy taken for analysis
Who cannot join
- Patient doesn't consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Trust
Oswestry, Shropsire, SY10 7AG
About this study
Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing.
- Being tested
- Genomic sequencing, Histological examination
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic sequencingDiagnostic test
Sequencing data
Histological examinationDiagnostic test
Images for deep learning
| Study group | Role | What they receive |
|---|---|---|
| Infection | Not described Receives: Diagnostic Test: Genomic sequencing; Diagnostic Test: Histological examination | |
| Tumours | Not described Receives: Diagnostic Test: Genomic sequencing; Diagnostic Test: Histological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequencing data and identification
Identification of infection and tumours using sequencing data
Measured: 3 years
Histological slides and identification
Deep learning using histological images
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start28 Jun 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumoursStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Collaborators
- Keele University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746001
- Sponsor's protocol ID
- 281854_47208_2021
- Acronym
- AIortho
- Status last verified
- Nov 2021
- First submitted
- 8 Feb 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be made available as part of publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection
- ClinicalTrials.gov ID
- NCT04746001
- Acronym / sponsor ID
- AIortho / 281854_47208_2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Collaborators
- Keele University
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 9 Feb 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.
Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection | – | Diagnostic Test: Genomic sequencing, Diagnostic Test: Histological examination |
| Tumours | – | Diagnostic Test: Genomic sequencing, Diagnostic Test: Histological examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected orthopaedic infection (including prosthetic joint infection) or bone tumours
Key inclusion criteria (1 listed)
- Suspected infection of bone tumour and biopsy taken for analysis
Key exclusion criteria (1 listed)
- Patient doesn't consent
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 |
|---|---|---|
| Genomic sequencingSequencing data | Diagnostic test | Infection, Tumours |
| Histological examinationImages for deep learning | Diagnostic test | Infection, Tumours |
Primary outcome
Sequencing data and identification
Time frame: 3 years
Identification of infection and tumours using sequencing data
Histological slides and identification
Time frame: 3 years
Deep learning using histological images
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Undecided. Data may be made available as part of publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tumours and Bone Infection, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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 11 Nov 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 United Kingdom. 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?
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?
Sequencing data and identification (time frame: 3 years). 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 11 Nov 2021.