DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
NCT ID: NCT05389774
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2023-03-23
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Are aged 35 years or above
* Have baseline CT study with at least one incidentally detected solid or part-solid (must have a solid component \>=80%) pulmonary nodule that:
* is not fully calcified
* Is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers
* Have baseline CT study that includes at least one series that meets all of the following (training for this will be provided):
* Is of a type that meets VNC instructions for use
* Comprises at least one full-inspiration breath-hold scans without a high degree of contrast media and does not exhibit quality issues (e.g., motion artefacts)
Exclusion Criteria
* Have received a diagnosis for cancer in the last 5 years
* Have thoracic implants that impact the image appearance of the nodule
* Have more than five reported pulmonary nodules of any size or type excluding fully calcified nodules (this criterion is used as a proxy due to the risk of being an infection or metastasis)
* Have one or more additional nodules where any of the following applies:
* Are already undergoing follow-up according to pulmonary nodule management standard care
* Pure ground glass opacity (GGO) of \>=5mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
* \>30mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
35 Years
ALL
No
Sponsors
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Optellum Ltd.
UNKNOWN
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Locations
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Betsi Cadwaladr University Health Board
Bangor, , United Kingdom
Frimley Health NHS Foundation Trust (Wexham Park Hospital)
Frimley, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Facility Contacts
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References
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O'Dowd E, Berovic M, Callister M, Chalitsios CV, Chopra D, Das I, Draper A, Garner JL, Gleeson F, Janes S, Kennedy M, Lee R, Mauri F, McKeever TM, McNulty W, Murray J, Nair A, Park J, Rawlinson J, Sagoo GS, Scarsbrook A, Shah P, Sudhir R, Talwar A, Thakrar R, Watkins J, Baldwin DR. Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study. BMJ Open. 2024 Jan 4;14(1):e077747. doi: 10.1136/bmjopen-2023-077747.
Other Identifiers
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21RM052
Identifier Type: -
Identifier Source: org_study_id
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