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

Not Applicable

Active, not recruiting

• Conditions: Atheroma; Chronic Bronchitis; Lung Cancer; Smoking-related Pathology; Non-progressive Cancer > 5 Years
• Interventions: Device: thoracic scan Low dose; Biological: BLOOD SAMPLE; Biological: FECES SAMPLE

• Registration Number: NCT05649046
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-13
• Study Start: 2023-01-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	BLOOD SAMPLE	-
patients	thoracic scan Low dose	-
patients	FECES SAMPLE	-

Primary Outcome Measures

Name	Time	Method
number of complete phenotyping clinical, clinical	18 months
number of complete phenotyping biological samples	18 months
number of complete phenotyping radiological	18 months

Secondary Outcome Measures

Name	Time	Method
Number of lung cancers diagnosed / Number of patients included	18 MONTHS
Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed	18 MONTHS
Satisfaction assessment	2 times (inclusion, 8 months)	by scale SF-12
Number of oncological events (other than lung cancer) / number of patients included	18 months
Number of patients in partial smoking cessation / number of active smoking patients included	18 MONTHS
Assessment of ANXIETY	2 times (inclusion, 8 months)	by scale STAI-YA
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

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France