NCT03654105Active, not recruitingPhase 2
Screening and Multiple Intervention on Lung Epidemics
Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 14 Aug 2018
- Start date
- 23 Jul 2019
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Lung cancer
- NCT number
- NCT03654105
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 2000
- From 23 Jul 2019 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic treatment with acetylsalicylic acid, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol)
- Treatment with methotrexate
- Previous treatment with Cytisine
- Abuse of alcohol or other substances (even previous)
Other illness
- History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal anti-inflammatory drugs
- Gastroduodenal ulcer
- Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency)
- Serious psychiatric problems
Lab values
- Hypersensitivity to acetylsalicylic acid, salicylates or any of the excipients (excipients: cellulose powder, corn starch, coating: copolymers of methacrylic acid, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate)
Other
- Existing Mastocytosis
- Hemorrhagic diathesis
Who the study is looking for
- Age between 55 and 75 years
- High consumption of cigarettes (≥ 30 packs/year)
- Elegibility to annual LDCT screening
- Confidence in Internet use
- Absence of tumors for at least 5 years
- Signed informed consent form
Age in the registry: 55 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.