PRogetto Salute Parma

Lung Cancer Clinical Trial

— PSP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04282694
• Other study ID #: 837/2019/OSS/UNIPR
• Status: Terminated
• Start date: February 12, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2020
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Smoking
• Smoking Cessation
• Smoking Habit
• Smoking, Cigarette
• Smoking, Tobacco

Intervention

Diagnostic Test:
• Low-dose computed tomography (LDCT)
Early detection of lung cancer by LDCT and smoking cessation counselling

Locations

Country	Name	City	State
Italy	University of Parma	Parma

Sponsors (3)

Lead Sponsor	Collaborator
University of Parma	Azienda Ospedaliero-Universitaria di Parma, Azienda Unità Sanitaria Locale (AUSL) di Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Organization model	To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization	18 months
Secondary	Smoking cessation	To measure the variation in smoking habits in enrolled smokers.	24 months
Secondary	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
Secondary	Work up burden	To measure the demand for further diagnostic investigations and treatment generated by LDCT.	24 months
Secondary	False positives	To measure the number of false positives generated by LDCT	24 months