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

Lung Cancer Clinical Trial

— PREVALUNG*  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05649046
• Other study ID #: RCAPHM22_0184
• Secondary ID: 2022-A01268-35
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atheroma
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Lung Cancer
• Lung Neoplasms
• Plaque, Atherosclerotic

Intervention

Device:
• thoracic scan Low dose
within 3 months after the V0 visit

Biological:
• BLOOD SAMPLE
within 3 months after the V0 visit
• FECES SAMPLE
within 3 months after the V0 visit

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of complete phenotyping clinical, clinical		18 months
Primary	number of complete phenotyping radiological		18 months
Primary	number of complete phenotyping biological samples		18 months
Secondary	Number of lung cancers diagnosed / Number of patients included		18 MONTHS
Secondary	Number of stage = IIB lung cancers / number of lung cancers diagnosed		18 MONTHS
Secondary	Number of patients in partial smoking cessation / number of active smoking patients included		18 MONTHS
Secondary	Satisfaction assessment	by scale SF-12	2 times (inclusion, 8 months)
Secondary	Assessment of ANXIETY	by scale STAI-YA	2 times (inclusion, 8 months)
Secondary	Number of initial positive scans / number of initial scans		18 months
Secondary	Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures		18 months
Secondary	Number of cardiovascular events / number of patients included		18 months
Secondary	Number of oncological events (other than lung cancer) / number of patients included		18 months