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*)

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Active, not recruiting

Conditions

Chronic Bronchitis

Atheroma

Lung Cancer

Non-progressive Cancer > 5 Years

Smoking-related Pathology

Treatments

Device: thoracic scan Low dose

Biological: FECES SAMPLE

Biological: BLOOD SAMPLE

Study type

Interventional

Funder types

Other

Identifiers

NCT05649046

2022-A01268-35 (Other Identifier)

RCAPHM22_0184

Details and patient eligibility

About

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

Enrollment

160 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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