ClinicalTrials.gg
RecruitingNCT05389774DOLCEUpdated Apr 8, 2025

DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution

An observational study in AI (Artificial Intelligence), Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, sponsored by Nottingham University Hospitals NHS Trust. Recruiting at 10 sites in United Kingdom. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Nottingham University Hospitals NHS Trust · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
35 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • AI (Artificial Intelligence)
  • Pulmonary Nodule, Solitary
  • Pulmonary Nodule, Multiple
  • Lung Cancer
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In context

Solitary Pulmonary Nodule

93 studies on the registry are indexed under Solitary Pulmonary Nodule; 20 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 401 across 45 observational studies indexed under Solitary Pulmonary Nodule.

Browse Solitary Pulmonary Nodule studies →

Lead sponsor

Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 )
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Determine the potential effect of the LCP on discharge

    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)

    Time frame: up to 1 year.

Secondary outcomes

  1. Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.

    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

    Time frame: up to 1 year.

  2. Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes.

    Measured difference between standard care, LCP and LCP-guided care for: * Percentage of thoracic, respiratory or vascular events related to biopsies or surgical excisions for lung nodules or suspected lung cancer occurring within 30 days of the procedure on benign-nodule patients * Percentage of lung cancers stratified by stage * Time in days between nodule detection and lung cancer diagnosis

    Time frame: up to 1 year.

  3. Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care

    Measured difference between standard care, LCP and LCP-guided care for: * The composite standardized GBP costs of all healthcare-related activity for lung nodules or suspected lung cancer * Health-related utilities (life years and QALYs)

    Time frame: up to 1 year.

  4. Determine the potential effect of the LCP on possible adherence to clinical guidelines.

    Measured difference between standard care and LCP-guided care for : Number and percentage of patients for whom a validated risk model (Brock or LCP) is used to guide the next clinical management step (i.e., counting the instances where Brock is not used, or where LCP is not possible to compute or it is ignored).

    Time frame: up to 1 year.

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Study locations

10 of 10 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05389774
Collaborators
Optellum Ltd.
Responsible party
Sponsor
First posted
May 25, 2022
Start date
Mar 23, 2023
Primary completion
Aug 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Apr 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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