Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Betsi Cadwaladr University Health Board
Coordinator of this site? Confirm its status
BangorUnited KingdomRecruiting
Frimley Health NHS Foundation Trust (Wexham Park Hospital)
Coordinator of this site? Confirm its status
FrimleyUnited KingdomRecruiting
Leeds Teaching Hospitals NHS Trust
Coordinator of this site? Confirm its status
LeedsUnited KingdomRecruiting
King's College Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
University College London Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
St. George's University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Royal Marsden NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Royal Free Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Nottingham University Hospitals NHS Trust
Coordinator of this site? Confirm its status
NottinghamUnited KingdomRecruiting
Oxford University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
OxfordUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.