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

Study acronym: DOLCE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 8, 2025 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Jan 2025 to Aug 2025v7
  2. Primary completion date: Jun 2024 to Jan 2025
    • Study sites: 11 to 10
    • Study completion date: Aug 2024 to Jan 2025
    v6
  3. Study sites: 12 to 11v5
  4. Study sites: 10 to 12
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 3 to 4
    v4
  5. Site details revised at 2 of 10 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2022 to Mar 23, 2023
    • Site details revised at 10 of 10 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05389774
Lead Sponsor Nottingham University Hospitals NHS Trust
Collaborators: Optellum Ltd.
Conditions
(from sponsor)		 AI (Artificial Intelligence), Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple, Lung Cancer
Related terms Lung Neoplasms, Multiple Pulmonary Nodules, Solitary Pulmonary Nodule
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov