Clinical trial NCT05649046: Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE
Official title: Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking-related Pathology
Atheroma
Chronic Bronchitis
Non-progressive Cancer > 5 Years
Lung Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: number of complete phenotyping clinical, clinical
timeFrame: 18 months
measure: number of complete phenotyping radiological
timeFrame: 18 months
measure: number of complete phenotyping biological samples
timeFrame: 18 months
Secondary outcomes:
measure: Number of lung cancers diagnosed / Number of patients included
timeFrame: 18 MONTHS
measure: Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed
timeFrame: 18 MONTHS
measure: Number of patients in partial smoking cessation / number of active smoking patients included
timeFrame: 18 MONTHS
measure: Satisfaction assessment
timeFrame: 2 times (inclusion, 8 months)
measure: Assessment of ANXIETY
timeFrame: 2 times (inclusion, 8 months)
measure: Number of initial positive scans / number of initial scans
timeFrame: 18 months
measure: Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures
timeFrame: 18 months
measure: Number of cardiovascular events / number of patients included
timeFrame: 18 months
measure: Number of oncological events (other than lung cancer) / number of patients included
timeFrame: 18 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE
name: Emilie GARRIDO PRADALIE
role: STUDY_DIRECTOR
References: