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Not yet recruitingNCT07921719PROMETHEEUpdated Nov 6, 2026

PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program

An observational study in Smoking Cessation and Lung Cancer Screening, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Hospices Civils de Lyon · Observational

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
5,400
Ages
50 Years to 74 Years
Sex
All
01

Study summary

This prospective observational study aims to evaluate whether an intensive tele-tobacco cessation program delivered through the PROMETHEE platform improves smoking cessation among smokers participating in the French national lung cancer screening pilot program IMPULSION. Participants receiving the PROMETHEE pathway will be compared with matched controls receiving standard smoking cessation support available through IMPULSION. The primary endpoint is self-reported smoking cessation at 12 months.

Read the detailed description

Lung cancer remains the leading cause of cancer-related mortality in France. Smoking cessation is a key component of lung cancer screening programs. The French national pilot screening program IMPULSION systematically proposes smoking cessation support to smokers; however, access to tobacco treatment services is heterogeneous across regions.

PROMETHEE was developed to provide a shared tele-tobacco cessation platform accessible to participating IMPULSION centers. The intervention relies on specialized tobacco-treatment nurses, facilitated access to teleconsultations, structured follow-up, and systematic prescription of evidence-based smoking cessation therapies, including nicotine replacement therapy or varenicline when appropriate.

The study is a prospective, non-randomized, nested case-control cohort study. Participants receiving care through PROMETHEE will be compared with matched controls selected from the IMPULSION database using a 2:1 matching ratio based on age and sex. No additional study-specific procedures or data collection are required beyond routine care and the existing IMPULSION information system.

02

Conditions studied

  • Smoking Cessation
  • Lung Cancer Screening

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Keywords

  • Smoking Cessation
  • Program IMPULSION
  • Tele-tobacco cessation platform PROMETHEE
03

In context

Smoking Cessation

1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

This study's planned enrollment of 5,400 is above the median of 216 across 116 observational studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

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

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Participants enrolled in the French IMPULSION lung cancer screening pilot program who are active smokers or have stopped smoking within one month before enrollment.

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

PROMETHEE Group:

  • Enrolled in IMPULSION
  • Active smoker or smoking cessation within the previous month
  • Referred to PROMETHEE by an IMPULSION investigator

Control Group:

  • Enrolled in IMPULSION
  • Active smoker or smoking cessation within the previous month
  • Not referred to PROMETHEE
  • Selected from the IMPULSION database
  • Matched by age (±5 years) and sex

Exclusion criteria

Exclusion Criteria:

  • Control subjects already included in PROMETHEE
  • Any exclusion criterion applicable under the IMPULSION program itself
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
5,400 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • PROMETHEE Cohort

    Participants enrolled in IMPULSION and referred to the PROMETHEE tele-tobacco platform. The pathway includes facilitated access to smoking cessation specialists, up to four follow-up teleconsultations, and systematic consideration of pharmacological cessation treatment.

    Other: PROMETHEE Cohort

  • Control Cohort

    Matched IMPULSION participants receiving standard smoking cessation support according to local resources and the routine IMPULSION program

    Other: Control Cohort

Interventions

  • OtherPROMETHEE Cohort

    PROMETHEE tele-tobacco platform

  • OtherControl Cohort

    Routine IMPULSION Cohorte

06

What researchers measure

Primary outcomes

  1. Self-reported Smoking Cessation at 12 Months

    Proportion of participants reporting smoking cessation 12 months after inclusion through the IMPULSION electronic follow-up questionnaire.

    Time frame: 12 months

07

Study locations

1 site
  • Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon
    Pierre-Bénite, 69310, France
08

Timeline

1 registry update 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

Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.

Of 42 non-industry observational studies under Smoking Cessation, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 90. This study's planned 36 months is above that.

Counting every sponsor, half of 47 studies reached it within 31 months; a quarter within 17 and three quarters within 90.

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

Registered
Oct 27, 2026
First posted
Nov 6, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2030
CompletionEst.
Jan 2030
Last update
Nov 6, 2026
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.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07921719
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2030 (estimated)
Completion
Jan 2030 (estimated)
Last update
Nov 6, 2026

Study contacts

Emmanuel GROLLEAU, MD
Contact
emmanuel.grolleau@chu-lyon.fr
4 78 86 44 01 ext. +33
Sébastien COURAUD, MD
Contact
sebastien.couraud@chu-lyon.fr
4 78 86 44 01 ext. +33

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 not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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