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PRogetto Salute Parma (PSP)

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ClinicalTrials.gov Identifier: NCT04282694
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Azienda Ospedaliero-Universitaria di Parma
Azienda Unità Sanitaria Locale (AUSL) di Parma
Information provided by (Responsible Party):
University of Parma

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.


Condition or disease Intervention/treatment
Smoking Smoking Habit Smoking, Tobacco Smoking, Cigarette Smoking Cessation Lung Cancer Diagnostic Test: Low-dose computed tomography (LDCT)

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRogetto Salute Parma: PRevenzione Primaria e Secondaria Del Danno da Fumo
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


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 Name: Smoking cessation




Primary Outcome Measures :
  1. Adherence [ Time Frame: 12 months ]
    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 Outcome Measures :
  1. Organization model [ Time Frame: 18 months ]
    To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization

  2. Smoking cessation [ Time Frame: 24 months ]
    To measure the variation in smoking habits in enrolled smokers.

  3. Secondary prevention of lung cancer [ Time Frame: 24 mesi ]
    To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site.

  4. Work up burden [ Time Frame: 24 months ]
    To measure the demand for further diagnostic investigations and treatment generated by LDCT.

  5. False positives [ Time Frame: 24 months ]
    To measure the number of false positives generated by LDCT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282694


Contacts
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Contact: Nicola Sverzellati, MD, PhD +390521702417 nicola.sverzellati@unipr.it
Contact: Mario Silva, MD, PhD +390521703660 mario.silva@unipr.it

Locations
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Italy
University of Parma Recruiting
Parma, Italy
Contact: Nicola Sverzellati, MD, PhD    +390521702417    nicola.sverzellati@unipr.it   
Contact: Mario Silva, MD, PhD    +390521703660    mario.silva@unipr.it   
Sponsors and Collaborators
University of Parma
Azienda Ospedaliero-Universitaria di Parma
Azienda Unità Sanitaria Locale (AUSL) di Parma
Investigators
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Principal Investigator: Nicola Sverzellati, MD, PhD University of Parma
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Responsible Party: University of Parma
ClinicalTrials.gov Identifier: NCT04282694    
Other Study ID Numbers: 837/2019/OSS/UNIPR
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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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