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Screening and Multiple Intervention on Lung Epidemics

Study acronym: SMILE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 3 versions Re-verified since Feb 27, 2023, no change to tracked fieldsv9-v11
  2. Primary completion date: Dec 2022 to Dec 31, 2024
    • Study completion date: Dec 2022 to Dec 31, 2026
    v8
  3. Primary and study completion dates: Jul 2022 to Dec 2022v7
  4. Primary and study completion dates: Jul 2021 to Jul 2022v6
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 2021 to Jul 2021
    • Start date changed from estimate of May 2019 to Jul 23, 2019
    • Site details revised
    v4
  2. Primary and study completion dates: Oct 2020 to May 2021
    • Start date: Oct 2018 to May 2019
    v3
  3. Secondary endpoints: details revised at 2 of 8 entriesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 prospective randomized pilot trial will evaluate a multiple intervention program of prevention in lifelong smokers aiming at reduction of chronic inflammation status through treatment with low-dose acetylsalicylic acid (ASA), smoking cessation with cytisine, targeted modification of diet and physical activity, in addition to early diagnosis with annual ultra low-dose spiral computed tomography (LDCT).
Trial Details
NCT Number NCT03654105
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators: Istituto Di Ricerche Farmacologiche Mario Negri
Conditions
(from sponsor)		 Inflammation, Smoking Cessation, Diet Modification, Physical Activity, Lung Cancer
Related terms Inflammation, Lung Neoplasms, Motor Activity, Smoking Cessation
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov