PRogetto Salute Parma (PSP)

PRogetto Salute Parma: PRevenzione Primaria e Secondaria Del Danno da Fumo

This project from the University Hospital of Parma (AOUPR) aims to verify the feasibility of a prevention program in our district, relying on advanced technological resources and highly experienced team in lung cancer early diagnosis, in order to identify useful elements towards the applicability of such a prevention program on a large scale (regional, national).

Uncontrolled, monocentric experimental study with dynamic enrollment and prospective data collection, aimed at implementing a prevention program based on scientific evidence. This study is set to verify the applicability and feasibility of a lung cancer prevention program in a real context, including a preliminary evaluation at the smoking cessation clinic and a LDCT assessment with subsequent LDCT follow-up for participants who show indeterminate findings at the first LDCT (LDCT baseline) exam.

The main objective of the study is to verify the feasibility of a lung cancer prevention program according to internationally validated scientific methods.

Secondary objectives:

1. To evaluate the use of local smoking cessation clinics and their effects in terms of smoking cessation (primary prevention)
2. To evaluate the outcomes of the program in terms of number of patients with early (presymptomatic) lung cancer treated with minimally invasive surgery (secondary prevention)
3. To evaluate the number of false positives and their diagnostic work-up (PET-CT, CT-guided biopsy, bronchoscopy)

Primary endpoint:

- Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months

Secondary endpoints:

• To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization
• To measure the variation in smoking habits in enrolled smokers
• To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site
• To measure the consequent demand for further diagnostic investigations and treatment
• To measure the number of false positives

Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program.

Inclusion criteria

• Age between 50 and 75 years
• Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years
• Status of current smoker or ex-smoker for <10 years.

Exclusion criteria

• Personal history of cancer within the prior 5 years

We expect to recruit around 500 people in 1 year. This sample size is considered adequate based on the available resources, both human and economic.

After closing and adjusting the database and before data analysis, a document called Statistical Analysis Plan (SAP) will be drawn up. It will consist of the following paragraphs:

• Statistical methods planned in the study protocol;
• Size of the sample;
• Management of missing data;
• Evaluation of the endpoints;
• Statistical models that will be applied in the analysis. The socio-demographic characteristics of the enrolled subjects, the adopted organizational methods and the effects of the prevention program (endpoints) will be analyzed and described using tables and figures.

The project "PRogetto Salute Parma: Primary and secondary prevention of smoking-related lung cancer" will be started once approved by the institutional Ethics Committee and authorized by the General Manager. The study is expected to be carried out over 2 years (from the inclusion of the first subject), with an expected period of 1 year for the enrolment and 1 further year for follow-up.

Study Overview

• Status: Terminated
• Conditions: Smoking; Smoking Cessation; Lung Cancer; Smoking, Tobacco; Smoking, Cigarette; Smoking Habit
• Intervention / Treatment: Diagnostic test: Low-dose computed tomography (LDCT)

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy
    • University of Parma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We expect to recruit around 500 people in 1 year. This sample size is considered adequate based on the available resources, both human and economic.

Description

Inclusion Criteria:

• Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years
• Status of current smoker or ex-smoker for <10 years.

Exclusion Criteria:

• Personal history of cancer within the prior 5 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

High risk (former) smokers; Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program. Inclusion criteria; Age between 50 and 75 years; Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years; Status of current smoker or ex-smoker for <10 years. Exclusion criteria • Personal history of cancer within the prior 5 years

Diagnostic test: Low-dose computed tomography (LDCT); Early detection of lung cancer by LDCT and smoking cessation counselling; Other Names: Smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organization model	To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization	18 months
Smoking cessation	To measure the variation in smoking habits in enrolled smokers.	24 months
Secondary prevention of lung cancer	To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site.	24 mesi
Work up burden	To measure the demand for further diagnostic investigations and treatment generated by LDCT.	24 months
False positives	To measure the number of false positives generated by LDCT	24 months

Collaborators and Investigators

• Sponsor: University of Parma
• Collaborators: Azienda Ospedaliero-Universitaria di Parma; Azienda Unità Sanitaria Locale (AUSL) di Parma
• Investigators: Principal Investigator: Nicola Sverzellati, MD, PhD, University of Parma

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2020
• Primary Completion (ACTUAL): October 30, 2020
• Study Completion (ACTUAL): October 30, 2020

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (ACTUAL): February 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 837/2019/OSS/UNIPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No