PRogetto Salute Parma

NCT04282694 | Terminated DMC FDA Device

• 1 other identifier: 837/2019/OSS/UNIPR
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Organization model

  18 months

• Smoking cessation

  24 months

• Secondary prevention of lung cancer

  24 mesi

• Work up burden

  24 months

• False positives

  24 months

Study Arms (1)

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)

Interventions

Low-dose computed tomography (LDCT) DIAGNOSTIC_TEST

Early detection of lung cancer by LDCT and smoking cessation counselling

Also known as: Smoking cessation

High risk (former) smokers

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Personal history of cancer within the prior 5 years

Sponsors & Collaborators

• University of Parma: lead
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• Azienda Unità Sanitaria Locale di Parma: collaborator

Study Sites (1)

University of Parma

Parma, Italy

Location

MeSH Terms

Conditions

Smoking; Tobacco Smoking; Cigarette Smoking; Smoking Cessation; Lung Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use; Health Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Nicola Sverzellati, MD, PhD

  University of Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 25, 2020
• Study Start: February 12, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 19, 2021

Record last verified: 2020-02

Locations

IT (1)