Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE
NCT ID: NCT05649046
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
160 participants
INTERVENTIONAL
2023-01-23
2024-06-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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patients
thoracic scan Low dose
within 3 months after the V0 visit
BLOOD SAMPLE
within 3 months after the V0 visit
FECES SAMPLE
within 3 months after the V0 visit
Interventions
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thoracic scan Low dose
within 3 months after the V0 visit
BLOOD SAMPLE
within 3 months after the V0 visit
FECES SAMPLE
within 3 months after the V0 visit
Eligibility Criteria
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Inclusion Criteria
* 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
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
* 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
45 Years
80 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Emilie GARRIDO PRADALIE
Role: STUDY_DIRECTOR
ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE
Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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Other Identifiers
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2022-A01268-35
Identifier Type: OTHER
Identifier Source: secondary_id
RCAPHM22_0184
Identifier Type: -
Identifier Source: org_study_id
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