Acetylsalicylic acid for High risk for lung cancer|Systemic inflammatory state|Tobacco dependence

Inclusion criteria

• {"criterion_text":"- Age between 55 and 75 years\n- Heavy smoker\n- Eligibility to screening with annual chest CT\n- Availability and ability to use the Internet via PC, tablet or smartphone\n- Ability to understand the project to which you intend to participate\n- No tumors in the last 5 years\n- Signature of informed consent for enrollment in the study and for the processing of personal data"}

Exclusion criteria

• {"criterion_text":"- 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)\n- Serious psychiatric problems\n- Abuse of alcohol or other substances (even before)\n- Chronic treatment with cardioASA, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol)\n- Treatment with methotrexate\n- Existing Mastocytosis\n- History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal antiinflammatory drugs\n- Gastroduodenal ulcer\n- Hemorrhagic diathesis\n- Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency)\n- Severe kidney failure"}

Primary endpoints

• {"endpoint_text":"- Reduction in the percentage of subjects with PCR ≥2 mg/L after one year of treatment in the interventional groups versus control group.","definition_or_measurement_approach":"Proportion of subjects with CRP (PCR) ≥2 mg/L measured after one year of treatment; comparison of interventional groups versus control group."}

Secondary endpoints

• {"endpoint_text":"- Reduction of the proportion of smokers after one year of follow-up in the intervention group on smoking cessation over the control group","definition_or_measurement_approach":"Proportion of smokers at one year in smoking-cessation intervention group versus control."}
• {"endpoint_text":"- Greater adherence to the Mediterranean Diet, measured through specific indexes defined in scientific literature (such as the MDS), The inflammatory status group with respect to the control group","definition_or_measurement_approach":"Adherence measured by established indices (e.g., Mediterranean Diet Score, MDS); comparison of inflammatory-status intervention group versus control."}
• {"endpoint_text":"- Increased physical activity, quantified in terms of Metabolic Equivalence of the Task (MET) in the inflammatory response group compared to the control group","definition_or_measurement_approach":"Physical activity quantified as METs (Metabolic Equivalent of Task); compare intervention vs control."}
• {"endpoint_text":"- Reduction of the various anthropometric parameters (IMC, waist circumference, waist circumference / waist ratio) and greater prevalence of weight-weight subjects in the inflammatory intervention group versus the control group","definition_or_measurement_approach":"Anthropometric measures (BMI/IMC, waist circumference, waist-to-hip ratio) compared between groups; prevalence of normal-weight subjects assessed."}
• {"endpoint_text":"- Reduction of cardio-metabolic markers in the blood in the inflammatory group compared to the control group","definition_or_measurement_approach":"Blood cardio-metabolic biomarker levels compared between inflammatory intervention group and control."}
• {"endpoint_text":"- Better quality of life, quantified by SF- 12 in intervention groups compared to control group","definition_or_measurement_approach":"Quality of life measured by SF-12 questionnaire; compare scores intervention vs control."}
• {"endpoint_text":"- Reduction of the incidence rate of lung cancer in the intervention group on smoking cessation with respect to the control group","definition_or_measurement_approach":"Incidence rate of lung cancer compared between smoking-cessation intervention group and control over follow-up period."}
• {"endpoint_text":"- Reduction of the total mortality rate in the intervention groups compared to the control group","definition_or_measurement_approach":"Total mortality rates compared between intervention groups and control."}
• {"endpoint_text":"- Evaluation of the relationship between inflammatory profile (PCR) plasma biomarkers and cardio-metabolic profile and microRNA profile","definition_or_measurement_approach":"Correlation/associations between plasma inflammatory biomarkers (CRP/PCR), cardio-metabolic biomarkers and microRNA profiles."}
• {"endpoint_text":"- Reduction in percentage of smokers and adverse reactions after one year of follow-up in subjects treated with Cytisine with prolonged administration compared to standard drug administration","definition_or_measurement_approach":"Compare smoking cessation rates and adverse reaction rates at one year in subjects receiving prolonged cytisine administration versus standard administration."}

Methods

• Recruitment from subjects eligible for annual chest CT screening for lung cancer (candidates to lung cancer early detection CT program) in Italy
• Requirement that participants have availability and ability to use the Internet via PC, tablet or smartphone implies use of digital channels for some study activities and recruitment/communication

Italy

Earliest CTIS Part Ii Submission Date

03-05-2024

Latest Decision Or Authorization Date

05-08-2024

Processing Time Days

94

Number Of Sites

1

Number Of Participants

2000

Primary sponsor

Full Name

Fondazione IRCCS Istituto Nazionale Dei Tumori

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy