DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AI (Artificial Intelligence), Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple, Lung Cancer. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes
Overview
This study is a multi-centre prospective observational cohort study recruiting patients with 5-30mm solid and part-solid pulmonary nodules that have been detected on CT chest scans performed as part of routine practice. The aim is to determine whether physician decision making with the AI-based LCP tool, generates clinical and health-economic benefits over the current standard of care of these patients.
Primary outcome measures
- Determine the potential effect of the LCP on discharge [Time frame: up to 1 year.]
Secondary outcome measures (4)
- Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization. [Time frame: up to 1 year.]
- Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes. [Time frame: up to 1 year.]
- Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care [Time frame: up to 1 year.]
- Determine the potential effect of the LCP on possible adherence to clinical guidelines. [Time frame: up to 1 year.]
Eligibility criteria
Inclusion criteria
Patients are eligible for the study if all of the following apply:
- 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
Patients will be excluded from the study if any of the following apply:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 10 centers
- Betsi Cadwaladr University Health Board — Bangor
- Frimley Health NHS Foundation Trust (Wexham Park Hospital) — Frimley
- Leeds Teaching Hospitals NHS Trust — Leeds
- King's College Hospital NHS Foundation Trust — London
- Royal Free Hospital — London
- St. George's University Hospitals NHS Foundation Trust — London
- The Royal Marsden NHS Foundation Trust — London
- University College London Hospitals NHS Foundation Trust — London
- … and 2 more centers
Publications
- 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 incidentall PMID 38176863
Identifiers
NCT: NCT05389774 · 21RM052