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Active, not recruitingNCT05649046PREVALUNG*Updated Mar 18, 2024

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

An interventional study of thoracic scan Low dose and BLOOD SAMPLE in Smoking-related Pathology, Atheroma and Chronic Bronchitis, sponsored by Assistance Publique Hopitaux De Marseille. Active, not recruiting at 1 site in France. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
45 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Smoking-related Pathology
  • Atheroma
  • Chronic Bronchitis
  • Non-progressive Cancer > 5 Years
  • Lung Cancer
03

In context

Plaque, Atherosclerotic

105 studies on the registry are indexed under Plaque, Atherosclerotic; 27 are open to participants now.

This study's enrollment of 160 is close to the median of 160 across 51 interventional studies indexed under Plaque, Atherosclerotic.

Browse Plaque, Atherosclerotic studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.

Browse Assistance Publique Hopitaux De Marseille studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Age 45- 75 years and

  • Medical follow-up for a smoking-related pathology :
  • atheroma
  • / 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Other
    patients

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

Interventions

  • Devicethoracic scan Low dose

    within 3 months after the V0 visit

  • BiologicalBLOOD SAMPLE

    within 3 months after the V0 visit

  • BiologicalFECES SAMPLE

    within 3 months after the V0 visit

06

What researchers measure

Primary outcomes

  1. number of complete phenotyping clinical, clinical

    Time frame: 18 months

  2. number of complete phenotyping radiological

    Time frame: 18 months

  3. number of complete phenotyping biological samples

    Time frame: 18 months

Secondary outcomes

  1. Number of lung cancers diagnosed / Number of patients included

    Time frame: 18 MONTHS

  2. Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed

    Time frame: 18 MONTHS

  3. Number of patients in partial smoking cessation / number of active smoking patients included

    Time frame: 18 MONTHS

  4. Satisfaction assessment

    by scale SF-12

    Time frame: 2 times (inclusion, 8 months)

  5. Assessment of ANXIETY

    by scale STAI-YA

    Time frame: 2 times (inclusion, 8 months)

  6. Number of initial positive scans / number of initial scans

    Time frame: 18 months

  7. Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures

    Time frame: 18 months

  8. Number of cardiovascular events / number of patients included

    Time frame: 18 months

  9. Number of oncological events (other than lung cancer) / number of patients included

    Time frame: 18 months

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2023 (actual). Primary completion is estimated for Jun 2024, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2022
First posted
Dec 13, 2022
StartActual
Jan 23, 2023
Primary completionEst.
Jun 1, 2024
CompletionEst.
Jun 1, 2024
Last update
Mar 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05649046
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Dec 13, 2022
Start date
Jan 23, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Mar 18, 2024

Study contacts

Emilie GARRIDO PRADALIE
study director · ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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