ClinicalTrials.gg
RecruitingNCT05486455Updated Dec 6, 2022

Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers

An interventional study of Low-dose chest CT scan in Smoking, sponsored by Hospital St. Joseph, Marseille, France. Recruiting at 1 site in France. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-06.

Sponsored by Hospital St. Joseph, Marseille, France · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Nov 2022; still recruiting 4 years later.

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Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 36 studies in Smoking with a site in France — 7 open to participants now, 8 under way, none of them phase 3. Smoking · France.

Planned enrollment
2nd of 29
1,000 · median 135
Started
2022
with 2 others
No phase
19 of 36
6 open now
Registered
30th of 36
by date

Among the 36 studies in Smoking with a site in France, this one is the 2nd largest by planned enrollment of the 29 interventional ones that give a count, is one of 3 that started in 2022, is one of 19 with no phase, and was the 30th registered.

Smoking

1,510 studies on the registry are indexed under Smoking; 193 are open to participants now.

Browse Smoking studies →

Open to participants now

7 of the 36 studies in Smoking with a site in France are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 140 Smoking studies recruiting now, 74 (53%) set no upper age limit and 48 (34%) stop at 75 or younger; 3 take children under 18; 65 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.

03

Conditions studied

  • Smoking

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04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female 50-80 years old
  • Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)

Exclusion criteria

Exclusion Criteria:

  • Recent history of chest CT scan (within 12 months)
  • Person unable to climb 2 floors
  • Weight > 140kg
  • Personal history of cancer \< 5 years (currently being monitored by thoracic imaging)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    CT scan

    Diagnostic Test: Low-dose chest CT scan

Interventions

  • Diagnostic testLow-dose chest CT scan

    baseline, 1-year, 3-year and 5-year low-dose CT scan

06

What researchers measure

Primary outcomes

  1. Positive Predictive Value (PPV)

    Time frame: 5 years

Secondary outcomes

  1. Sensitivity

    Time frame: 5 years

  2. Specificity

    Time frame: 5 years

  3. Early stage lung cancer detection rate (stage I and II)

    Time frame: 5 years

  4. 5-year survival rate of patients who have undergone thoracic surgery

    Time frame: 5 years

  5. Rate of smoking-related co-morbidities detected on low-dose CT scan

    smoking-related co-morbities = pulmonary emphysema, interstitial lung disease, atheromatous disease, hepatic steatosis and ascending aortic aneurysm.

    Time frame: 5 years

  6. Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)

    Time frame: 5 years

  7. Risk ratio of lung cancer

    Time frame: 5 years

  8. Number of false positive results

    Time frame: 5 years

  9. Penetration rate

    number of subjects included / number of includible subjects

    Time frame: 5 years

  10. Smoking cessation rates

    Time frame: 5 years

  11. EORTC QLQ-C30 score (version 3)

    The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional and social), a global QOL scale, and 3 symptom scales (fatigue, pain and nausea/vomiting). In addition, several single item symptom measures are used. For the five functioning scales and the global quality of life scale, a higher score represents a better level of functioning. For the symptom scales and items, a high score corresponds to a higher level of symptomatology.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Oct 2028, 71 months after the start.

Of 402 non-industry interventional studies with no phase under Smoking, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 71 months is above that.

Counting every sponsor, half of 457 studies reached it within 23 months; a quarter within 8 and three quarters within 40.

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

Registered
Aug 1, 2022
First posted
Aug 3, 2022
StartActual
Nov 4, 2022
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2028
Last update
Dec 6, 2022
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 Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05486455
Lead sponsor
Hospital St. Joseph, Marseille, France
Responsible party
Sponsor
First posted
Aug 3, 2022
Start date
Nov 4, 2022
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Dec 6, 2022

Study contacts

Cecile Bielmann
Contact
cbielman@hopital-saint-joseph.fr
0033488731070
Arnaud Boyer, MD
principal investigator · Hopital Saint Joseph Marseille
Illies Bouabdallah, MD
study director · Hopital Saint Joseph Marseille

Oversight

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

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