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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2024-06-01

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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patients

Group Type OTHER

thoracic scan Low dose

Intervention Type DEVICE

within 3 months after the V0 visit

BLOOD SAMPLE

Intervention Type BIOLOGICAL

within 3 months after the V0 visit

FECES SAMPLE

Intervention Type BIOLOGICAL

within 3 months after the V0 visit

Interventions

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thoracic scan Low dose

within 3 months after the V0 visit

Intervention Type DEVICE

BLOOD SAMPLE

within 3 months after the V0 visit

Intervention Type BIOLOGICAL

FECES SAMPLE

within 3 months after the V0 visit

Intervention Type BIOLOGICAL

Eligibility Criteria

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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


* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

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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