Structuring of a Lung Cancer Screening Program Including... | NCT05649046

Studies
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

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Mar 18, 2024Actual

Enrollment

160Actual

Phase

Not Applicable

Conditions

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

Interventions

thoracic scan Low dose
BLOOD SAMPLE
FECES SAMPLE

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2022-A01268-35	Other Identifier	NUMERO IDRCB

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2023Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Oct 26, 2022

First Submission Date that Met QC Criteria

Dec 12, 2022

First Posted Date

Dec 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2024

Last Update Posted Date

Mar 18, 2024Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Label	Type	Description	Intervention Names
patients	Other		Device: thoracic scan Low dose Biological: BLOOD SAMPLE Biological: FECES SAMPLE

Name	Type	Description	Arm Group Labels	Other Names
thoracic scan Low dose	Device	within 3 months after the V0 visit	patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Emilie GARRIDO PRADALIE	ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille		Marseille		13354	France

Type	Date	Date Unknown
Release	Jul 30, 2025
Reset	Aug 14, 2025

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 30, 2025			Aug 14, 2025

ID	Term
D058226	Plaque, Atherosclerotic
D029481	Bronchitis, Chronic
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D029424	Pulmonary Disease, Chronic Obstructive
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques