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AI (Artificial Intelligence)DOLCENCT05389774

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

An observational study of AI (Artificial Intelligence) and Pulmonary Nodule, Solitary, run by Nottingham University Hospitals NHS Trust at 10 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 years and older
How many people
2,000 participants
Where
10 sitesUnited Kingdom
Study dates
23 Mar 2023to Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

10 sites in 1 country

United Kingdom10 sites, 10 recruiting

  • Betsi Cadwaladr University Health Board

    Bangor

    Daniel Menzies, 03000 856766, BCU.research&development@wales.nhs.uk

    Recruiting

  • Frimley Health NHS Foundation Trust (Wexham Park Hospital)

    Frimley

    Hussein Chreif, 0300 615 4191, fhft.research-innovation@nhs.net

    Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds

    Research & Innovation Department, 0113 206 0469, ltht.researchoffice@nhs.net

    Andrew Scarsbrook

    Recruiting

  • King's College Hospital NHS Foundation Trust

    London

    William McNulty, 020 3299 1980, kch-tr.research@nhs.net

    Recruiting

  • Royal Free Hospital

    London

    James Murray, 020 7317 7558, rf.randd@nhs.net

    Recruiting

  • St. George's University Hospitals NHS Foundation Trust

    London

    Adrian Draper, 020 8672 9944, researchgovernance@sgul.ac.uk

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London

    Richard Lee, 020 3186 5416, research.development@rmh.nhs.uk

    Lydia Taylor, 020 7808 2603, Lydia.Taylor@rmh.nhs.uk

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London

    Ricky Thakrar, 020 3447 9825, Uclh.randd@nhs.net

    Recruiting

  • Nottingham University Hospitals NHS Trust

    Nottingham

    David Baldwin, 0115 924 9924 ext. 80677, ResearchSponsor@nuh.nhs.uk

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford

    Fergus Gleeson, 01865 226116, CHRadiologyRd@ouh.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes

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.

Medical subject headings
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: up to 1 year.

Secondary outcomes (4)

  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

    Measured: 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

    Measured: 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)

    Measured: 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).

    Measured: up to 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start23 Mar 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05389774
Sponsor's protocol ID
21RM052
Acronym
DOLCE
Status last verified
Apr 2025
First submitted
16 May 2022
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • O'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.

    PubMed 38176863

Questions about this trial

What is this clinical trial studying?

An observational study of AI (Artificial Intelligence) and Pulmonary Nodule, Solitary, run by Nottingham University Hospitals NHS Trust at 10 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the potential effect of the LCP on discharge (time frame: up to 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05389774, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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