Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE (PREVALUNG*)

Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer > 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile

Determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer; Chronic Bronchitis; Smoking-related Pathology; Atheroma; Non-progressive Cancer > 5 Years
• Intervention / Treatment: Device: thoracic scan Low dose; Biological: BLOOD SAMPLE; Biological: FECES SAMPLE

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age 45- 75 years and

• Medical follow-up for a smoking-related pathology :
• atheroma
• chronic obstructive pulmonary disease / emphysema
• history of non evolving cancer > 5 years among: ENT, lung, breast, cervical, excreto-urinary cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia chronic myeloid leukemia,
• daily smoking for at least 10 years prior to the disease Or

NLST inclusion criteria:

• Age 55 - 74 years
• Cumulative smoking ≥ 30 pack-years
• active or quit for less than 15 years Or

Inclusion criterion in NELSON:

• Age 50-75 years
• Smoking:
• > 15 cigarettes/D for more than 25 years or
• > 10 cigarettes /D for more than 30 years
• Active smoking or cessation < 10 years Or

New American recommendations :

• Age 50 - 80 years
• Smoking ≥20 PA
• Active or weaned <15 years

Exclusion Criteria:

history of cancer < 5 years (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma basal cell carcinoma of the skin and prostate cancer with undetectable PSA)

• Symptoms of lung cancer (unintentional weight loss > 7 kg in 1 year, hemoptysis)
• known history of pulmonary nodule with specialized follow-up
• history of pulmonary fibrosis or pulmonary hypertension
• patient under guardianship or curatorship
• active pulmonary parenchymal infection
• severe cardiac or respiratory insufficiency (rest dyspnea)
• patient not affiliated to the social security system (beneficiary or beneficiary's right)
• Patient deprived of liberty
• Performance status (WHO) 2, 3 or 4
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients	Device: thoracic scan Low dose; within 3 months after the V0 visit; Biological: BLOOD SAMPLE; within 3 months after the V0 visit; Biological: FECES SAMPLE; within 3 months after the V0 visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of complete phenotyping clinical, clinical	18 months
number of complete phenotyping radiological	18 months
number of complete phenotyping biological samples	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of lung cancers diagnosed / Number of patients included		18 MONTHS
Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed		18 MONTHS
Number of patients in partial smoking cessation / number of active smoking patients included		18 MONTHS
Satisfaction assessment	by scale SF-12	2 times (inclusion, 8 months)
Assessment of ANXIETY	by scale STAI-YA	2 times (inclusion, 8 months)
Number of initial positive scans / number of initial scans		18 months
Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures		18 months
Number of cardiovascular events / number of patients included		18 months
Number of oncological events (other than lung cancer) / number of patients included		18 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Emilie GARRIDO PRADALIE, ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Bronchial Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Anatomical; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Lung Neoplasms; Bronchitis; Bronchitis, Chronic; Plaque, Atherosclerotic
• Other Study ID Numbers: RCAPHM22_0184; 2022-A01268-35 (Other Identifier: NUMERO IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No