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

Primary Purpose

Smoking-related Pathology, Atheroma, Chronic Bronchitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
thoracic scan Low dose
BLOOD SAMPLE
FECES SAMPLE
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking-related Pathology

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients

Arm Description

Outcomes

Primary Outcome Measures

number of complete phenotyping clinical, clinical
number of complete phenotyping radiological
number of complete phenotyping biological samples

Secondary Outcome Measures

Number of lung cancers diagnosed / Number of patients included
Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed
Number of patients in partial smoking cessation / number of active smoking patients included
Satisfaction assessment
by scale SF-12
Assessment of ANXIETY
by scale STAI-YA
Number of initial positive scans / number of initial scans
Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures
Number of cardiovascular events / number of patients included
Number of oncological events (other than lung cancer) / number of patients included

Full Information

First Posted
October 26, 2022
Last Updated
January 23, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05649046
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking-related Pathology, Atheroma, Chronic Bronchitis, Non-progressive Cancer > 5 Years, Lung Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
thoracic scan Low dose
Intervention Description
within 3 months after the V0 visit
Intervention Type
Biological
Intervention Name(s)
BLOOD SAMPLE
Intervention Description
within 3 months after the V0 visit
Intervention Type
Biological
Intervention Name(s)
FECES SAMPLE
Intervention Description
within 3 months after the V0 visit
Primary Outcome Measure Information:
Title
number of complete phenotyping clinical, clinical
Time Frame
18 months
Title
number of complete phenotyping radiological
Time Frame
18 months
Title
number of complete phenotyping biological samples
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of lung cancers diagnosed / Number of patients included
Time Frame
18 MONTHS
Title
Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed
Time Frame
18 MONTHS
Title
Number of patients in partial smoking cessation / number of active smoking patients included
Time Frame
18 MONTHS
Title
Satisfaction assessment
Description
by scale SF-12
Time Frame
2 times (inclusion, 8 months)
Title
Assessment of ANXIETY
Description
by scale STAI-YA
Time Frame
2 times (inclusion, 8 months)
Title
Number of initial positive scans / number of initial scans
Time Frame
18 months
Title
Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures
Time Frame
18 months
Title
Number of cardiovascular events / number of patients included
Time Frame
18 months
Title
Number of oncological events (other than lung cancer) / number of patients included
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra GIULIANI
Phone
0491382747
Email
alexandra.giuliani@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
David BOULATE
Email
david.boulate@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie GARRIDO PRADALIE
Organizational Affiliation
ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DAVID BOLATE
Email
david.boulate@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

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

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