Clinical trial · Observational
DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AI (Artificial Intelligence) | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pulmonary Nodule, Multiple | — | UNRESOLVED | — |
| Pulmonary Nodule, Solitary | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the potential effect of the LCP on discharge
- timeFrame
- up to 1 year.
- description
- Measured difference between standard care, LCP and LCP-guided care for: * Percentage of cancer patients discharged (straight after assessment of the baseline scan) * Percentage of benign-nodule patients discharged (straight after assessment of the baseline scan)
Secondary outcomes (4)
- measure
- Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.
- timeFrame
- up to 1 year.
- description
- Percentage of cancer patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (correctly by more aggressive management and incorrectly for less aggressive management). Percentage of benign-nodule patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (incorrectly by more aggressive management and correctly for less aggressive management). Measured difference between standard care, LCP and LCP-guided care for: * Percentage of CT scans and PET/CT scans performed on benign-nodule patients * Percentage of non-surgical biopsies performed on benign-nodule patients * Percentage of surgical excisions on benign-nodule patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDO'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. PMID 38176863