A randomized trial of multi-factorial primary prevention in high risk subjects candidate to a lung cancer early detection CT program

2024-513660-26-00 Protocol SMILE Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 6 Aug 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol SMILE

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 2,000
Countries 1
Sites 1

Subjects at high risk of inflammatory state and mortality from lung cancer, other cancers and all causes

The main objective of the study is to evaluate the efficacy of multi-factor intervention in high risk subjects in terms of inflammatory inflammation.

Key facts

Sponsor
Fondazione IRCCS Istituto Nazionale Dei Tumori
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
Trial duration
6 Aug 2024 → ongoing
Decision date (initial)
2024-08-05
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-513660-26-00
EudraCT number
2016-003036-20
WHO UTN
U0000-0000-0000
ClinicalTrials.gov
NCT00000000
ISRCTN
ISRCTN00000000

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy, Efficacy

The main objective of the study is to evaluate the efficacy of multi-factor intervention in high risk subjects in terms of inflammatory inflammation.

Secondary objectives 10

  1. Reduction in the proportion of smokers
  2. Improving the efficacy of Cytisine for smoking cessation, using an alternative way of administering the drug
  3. Improvement of diet and physical activity
  4. Improvement of anthropometric parameters in over-weight / obese and under-weight subjects
  5. Improvement of metabolic values
  6. Improving the quality of life
  7. Reduction in the percentage of subjects with lung cancer
  8. Reduction of total mortality
  9. Evaluation of the relationship between inflammatory profile (PCR) plasma biomakers and those related to the metabolic profile and microRNA profile
  10. Evaluation of the adherence, feasibility and tolerability of multi-factor prevention intervention

Conditions and MedDRA coding

Subjects at high risk of inflammatory state and mortality from lung cancer, other cancers and all causes

VersionLevelCodeTermSystem organ class
20.0 LLT 10036654 Prevention 10042613

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Age between 55 and 75 years
  2. Heavy smoker
  3. Eligibility to screening with annual chest CT
  4. Availability and ability to use the Internet via PC, tablet or smartphone
  5. Ability to understand the project to which you intend to participate
  6. No tumors in the last 5 years
  7. Signature of informed consent for enrollment in the study and for the processing of personal data

Exclusion criteria 11

  1. 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)
  2. Chronic treatment with cardioASA, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol)
  3. Treatment with methotrexate
  4. Existing Mastocytosis
  5. History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal antiinflammatory drugs
  6. Gastroduodenal ulcer
  7. Hemorrhagic diathesis
  8. Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency)
  9. Severe kidney failure
  10. Serious psychiatric problems
  11. Abuse of alcohol or other substances (even before)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Reduction in the percentage of subjects with PCR ≥2 mg/L after one year of treatment in the interventional groups versus control group.

Secondary endpoints 10

  1. Reduction of the proportion of smokers after one year of follow-up in the intervention group on smoking cessation over the control group
  2. 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
  3. Increased physical activity, quantified in terms of Metabolic Equivalence of the Task (MET) in the inflammatory response group compared to the control group
  4. 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
  5. Reduction of cardio-metabolic markers in the blood in the inflammatory group compared to the control group
  6. Better quality of life, quantified by SF- 12 in intervention groups compared to control group
  7. Reduction of the incidence rate of lung cancer in the intervention group on smoking cessation with respect to the control group
  8. Reduction of the total mortality rate in the intervention groups compared to the control group
  9. Evaluation of the relationship between inflammatory profile (PCR) plasma biomarkers and cardio-metabolic profile and microRNA profile
  10. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

CARDIOASPIRIN 100 mg Compresse gastroresistenti

PRD451506 · Product

Active substance
Acetylsalicylic Acid
Substance synonyms
ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
Pharmaceutical form
GASTRO-RESISTANT TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
B01AC06 — ACETYLSALICYLIC ACID
Marketing authorisation
024840098
MA holder
BAYER SPA
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tabex 1,5 mg tabletki powlekane

PRD359690 · Product

Active substance
Cytisine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
9 mg milligram(s)
Max total dose
411 mg milligram(s)
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
N07BA — DRUGS USED IN NICOTINE DEPENDENCE
Marketing authorisation
R/3425
MA holder
SOPHARMA WARSZAWA SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
galenic drug encapsulated in the hospital pharmacy

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione IRCCS Istituto Nazionale Dei Tumori

26 Total trials 16 Recruiting 4 Ended
Academic / Non-commercial
Sponsor organisation
Fondazione IRCCS Istituto Nazionale Dei Tumori
Address
Via Giacomo Venezian 1
City
Milan
Postcode
20133
Country
Italy

Scientific contact point

Organisation
Fondazione IRCCS Istituto Nazionale Dei Tumori
Contact name
Chirurgia Toracica

Public contact point

Organisation
Fondazione IRCCS Istituto Nazionale Dei Tumori
Contact name
Public Relation Office

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ongoing, recruiting 2,000 1
Rest of world — 0 —

Investigational sites

Italy

1 site · Ongoing, recruiting
Fondazione IRCCS Istituto Nazionale Dei Tumori
Toracic Surgery, Via Giacomo Venezian 1, 20133, Milan

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2024-08-06 2024-08-06

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-513660-26-00 redacted 4
Recruitment arrangements (for publication) K1_recruitment arrangments 1
Subject information and informed consent form (for publication) D4_Questionari di registrazione 1
Subject information and informed consent form (for publication) D4_Questionario Aderenza Dieta-QAD 1
Subject information and informed consent form (for publication) D4_Questionario Attivita Fisica-IPAQ 1
Subject information and informed consent form (for publication) D4_Questionario Compliance Citisina-QCCit 1
Subject information and informed consent form (for publication) D4_Questionario sulle Abitudini Alimentari24h 1
Subject information and informed consent form (for publication) L1_ICF_2024-513660-26-00 redacted 4
Subject information and informed consent form (for publication) L2_Lettera al medico curante_redact 1
Subject information and informed consent form (for publication) L2_Privacy 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_Acetylsalicylic acid 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_Cytisine 1
Synopsis of the protocol (for publication) D1_Synopsis 2024-513660-26-00 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-19 Italy Acceptable
2024-07-04
 2024-08-05