Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-27 @ 9:25 AM
Study NCT ID:
NCT04282694
Status:
TERMINATED
Last Update Posted:
2021-11-19
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRogetto Salute Parma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The worldwide surge of SARS-CoV-2 started during the first week of the study. The Investigators attempted to re-organize the project with a new agenda, but the time frame from the funding Organization did not comply with the study needs.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-10', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '12 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Organization model', 'timeFrame': '18 months', 'description': 'To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization'}, {'measure': 'Smoking cessation', 'timeFrame': '24 months', 'description': 'To measure the variation in smoking habits in enrolled smokers.'}, {'measure': 'Secondary prevention of lung cancer', 'timeFrame': '24 mesi', 'description': 'To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site.'}, {'measure': 'Work up burden', 'timeFrame': '24 months', 'description': 'To measure the demand for further diagnostic investigations and treatment generated by LDCT.'}, {'measure': 'False positives', 'timeFrame': '24 months', 'description': 'To measure the number of false positives generated by LDCT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Smoking', 'Smoking Habit', 'Smoking, Tobacco', 'Smoking, Cigarette', 'Smoking Cessation', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': '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).\n\nUncontrolled, 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.\n\nThe main objective of the study is to verify the feasibility of a lung cancer prevention program according to internationally validated scientific methods.\n\nSecondary objectives:\n\n1. To evaluate the use of local smoking cessation clinics and their effects in terms of smoking cessation (primary prevention)\n2. 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)\n3. To evaluate the number of false positives and their diagnostic work-up (PET-CT, CT-guided biopsy, bronchoscopy)\n\nPrimary endpoint:\n\n\\- 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\n\nSecondary endpoints:\n\n* To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization\n* To measure the variation in smoking habits in enrolled smokers\n* To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site\n* To measure the consequent demand for further diagnostic investigations and treatment\n* To measure the number of false positives\n\nSubjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program.\n\nInclusion criteria\n\n* Age between 50 and 75 years\n* Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years\n* Status of current smoker or ex-smoker for \\<10 years.\n\nExclusion criteria\n\n• Personal history of cancer within the prior 5 years\n\nWe expect to recruit around 500 people in 1 year. This sample size is considered adequate based on the available resources, both human and economic.\n\nAfter 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:\n\n* Statistical methods planned in the study protocol;\n* Size of the sample;\n* Management of missing data;\n* Evaluation of the endpoints;\n* 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years\n* Status of current smoker or ex-smoker for \\<10 years.\n\nExclusion Criteria:\n\n* Personal history of cancer within the prior 5 years'}, 'identificationModule': {'nctId': 'NCT04282694', 'acronym': 'PSP', 'briefTitle': 'PRogetto Salute Parma', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'PRogetto Salute Parma: PRevenzione Primaria e Secondaria Del Danno da Fumo', 'orgStudyIdInfo': {'id': '837/2019/OSS/UNIPR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk (former) smokers', 'description': 'Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program.\n\nInclusion criteria\n\n* Age between 50 and 75 years\n* Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years\n* Status of current smoker or ex-smoker for \\<10 years.\n\nExclusion criteria\n\n• Personal history of cancer within the prior 5 years', 'interventionNames': ['Diagnostic Test: Low-dose computed tomography (LDCT)']}], 'interventions': [{'name': 'Low-dose computed tomography (LDCT)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Smoking cessation'], 'description': 'Early detection of lung cancer by LDCT and smoking cessation counselling', 'armGroupLabels': ['High risk (former) smokers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Parma', 'country': 'Italy', 'facility': 'University of Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Nicola Sverzellati, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Parma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliero-Universitaria di Parma', 'class': 'OTHER'}, {'name': 'Azienda Unità Sanitaria Locale di Parma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}