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

April 4, 2025 updated by: Nottingham University Hospitals NHS Trust

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bangor, United Kingdom
      • Frimley, United Kingdom
        • Recruiting
        • Frimley Health NHS Foundation Trust (Wexham Park Hospital)
        • Contact:
      • Leeds, United Kingdom
        • Recruiting
        • Leeds Teaching Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Andrew Scarsbrook
      • London, United Kingdom
        • Recruiting
        • Royal Free Hospital
        • Contact:
      • London, United Kingdom
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
        • Contact:
      • London, United Kingdom
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
      • London, United Kingdom
      • London, United Kingdom
        • Recruiting
        • St. George's University Hospitals NHS Foundation Trust
        • Contact:
      • Nottingham, United Kingdom
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the potential effect of the LCP on discharge
Time Frame: up to 1 year.

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)
up to 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.
Time Frame: up to 1 year.

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
up to 1 year.
Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes.
Time Frame: up to 1 year.

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
up to 1 year.
Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care
Time Frame: up to 1 year.

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)
up to 1 year.
Determine the potential effect of the LCP on possible adherence to clinical guidelines.
Time Frame: up to 1 year.

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).
up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

Optellum Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21RM052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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