NCT05389774Recruiting
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 · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 16 May 2022
- Start date
- 23 Mar 2023
- Primary completion date
- Aug 2025
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Diseases
- Lung cancer
- NCT number
- NCT05389774
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 23 Mar 2023 to the primary completion date, Aug 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received a diagnosis for cancer in the last 5 years
- Have thoracic implants that impact the image appearance of the nodule
Other illness
- 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)
Other
- Patients will be excluded from the study if any of the following apply:
- 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
Who the study is looking for
- 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)
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Betsi Cadwaladr University Health Board Coordinator of this site? Confirm its status | Bangor | United Kingdom | Recruiting |
| Frimley Health NHS Foundation Trust (Wexham Park Hospital) Coordinator of this site? Confirm its status | Frimley | United Kingdom | Recruiting |
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St. George's University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.