Clinical trial NCT05389774: DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
Official title: DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AI (Artificial Intelligence)
Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Lung Cancer
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Optellum Ltd.
First posted: 2022-05-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The CT scans of patients for whom a pulmonary nodule has been identified will be reviewed for study eligibility by a member of the local site's clinical team for the patient.

Brief summary: 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.


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

Primary outcomes:
measure: Determine the potential effect of the LCP on discharge
timeFrame: up to 1 year.
Secondary outcomes:
measure: Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.
timeFrame: up to 1 year.
measure: Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes.
timeFrame: up to 1 year.
measure: Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care
timeFrame: up to 1 year.
measure: Determine the potential effect of the LCP on possible adherence to clinical guidelines.
timeFrame: up to 1 year.
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
city: Frimley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust (Wexham Park Hospital)
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St. George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
References: