Clinical trial NCT04282694: PRogetto Salute Parma
Official title: PRogetto Salute Parma: PRevenzione Primaria e Secondaria Del Danno da Fumo
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Smoking
Smoking Habit
Smoking, Tobacco
Smoking, Cigarette
Smoking Cessation
Lung Cancer
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria di Parma
name: Azienda Unità Sanitaria Locale di Parma
First posted: 2020-02-25
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Organization model
timeFrame: 18 months
measure: Smoking cessation
timeFrame: 24 months
measure: Secondary prevention of lung cancer
timeFrame: 24 mesi
measure: Work up burden
timeFrame: 24 months
measure: False positives
timeFrame: 24 months
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma
Study officials:
affiliation: University of Parma
name: Nicola Sverzellati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: