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

NCT05649046 | Active Not Recruiting

• 2 other identifiers: RCAPHM22_01842022-A01268-35
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Smoking-related Pathology; Atheroma; Chronic Bronchitis; Non-progressive Cancer > 5 Years; Lung Cancer

Outcome Measures

Primary Outcomes (3)

• number of complete phenotyping clinical, clinical

  18 months

• number of complete phenotyping radiological

  18 months

• number of complete phenotyping biological samples

  18 months

Secondary Outcomes (9)

• 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

  2 times (inclusion, 8 months)

• Assessment of ANXIETY

  2 times (inclusion, 8 months)

Study Arms (1)

patients

OTHER

Device: thoracic scan Low dose; Biological: BLOOD SAMPLE; Biological: FECES SAMPLE

Interventions

thoracic scan Low dose DEVICE

within 3 months after the V0 visit

patients

BLOOD SAMPLE BIOLOGICAL

within 3 months after the V0 visit

patients

FECES SAMPLE BIOLOGICAL

within 3 months after the V0 visit

patients

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic; Bronchitis, Chronic; Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emilie GARRIDO PRADALIE

  ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: December 13, 2022
• Study Start: January 23, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-02

Locations

FR (1)