NCT04746001

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

February 8, 2021

Last Update Submit

November 10, 2021

Conditions

Bone TumoursBone InfectionProsthetic Joint InfectionProsthetic Infection

Outcome Measures

Primary Outcomes (2)

  • Sequencing data and identification

    Identification of infection and tumours using sequencing data

    3 years

  • Histological slides and identification

    Deep learning using histological images

    3 years

Study Arms (2)

Infection

Diagnostic Test: Genomic sequencingDiagnostic Test: Histological examination

Tumours

Diagnostic Test: Genomic sequencingDiagnostic Test: Histological examination

Interventions

Genomic sequencingDIAGNOSTIC_TEST

Sequencing data

InfectionTumours
Histological examinationDIAGNOSTIC_TEST

Images for deep learning

InfectionTumours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with suspected orthopaedic infection (including prosthetic joint infection) or bone tumours

You may qualify if:

  • Suspected infection of bone tumour and biopsy taken for analysis

You may not qualify if:

  • Patient doesn't consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Trust

Oswestry, Shropsire, SY10 7AG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Histological slides and limited sequencing data

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 9, 2021

Study Start

June 28, 2021

Primary Completion

January 1, 2024

Study Completion

July 1, 2024

Last Updated

November 11, 2021

Record last verified: 2021-11

Locations

GB(1)