ClinicalTrials.gg
RecruitingNCT07331519ISC-LDCTUpdated Feb 6, 2026

Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer

An interventional study of Smartphone application and low-dose computed tomography in Smoking Cessation, sponsored by Oulu University Hospital. Recruiting at 5 sites in Finland. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Oulu University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study summary

The study investigates effectiveness of different smoking cessation methods and low-dose CT based lung cancer screening

Read the detailed description

The study population consists of individuals aged 50-74 years with a significant smoking history who continue to smoke. The study design is a prospective and participants are randomized into three study arms: low-dose CT (LDCT) + smoking cessation with a smartphone application (arm 1), LDCT + smoking cessation with written materials (arm 2), smoking cessation with a smartphone application without LDCT (arm 3). The study compares effectiveness of smoking cessation methods, LDCT in lung cancer screening, lung cancer stage distribution, and lung cancer specific survival.

02

Conditions studied

  • Smoking Cessation

Keywords

  • smoking cessation
  • lung cancer
  • low-dose CT
  • lung cancer screening
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 1,200 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 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
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

  1. Able to provide written
  2. Age between 50-74
  3. Smoked ≥ 15 cigarettes/day for ≥ 25 years or smoked ≥ 10 cigarettes/day for ≥ 30 years and are active smokers (smoking during the last two weeks)
  4. Access to a smartphone (iPhone or Android)

Exclusion criteria

Exclusion Criteria:

  1. Current or past melanoma, lung, renal or breast cancer
  2. A chest CT examination less than one year before inclusion
  3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  4. No access to a smartphone (iPhone or Android)
  5. Participant is unwilling or unable to comply with treatment and trial instructions
  6. Any condition that study investigators consider an impediment to safe trial participation
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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Arm 1

    Smoking cessation with a smartphone application + LDCT lung cancer screening

    Other: Smartphone application · Other: low-dose computed tomography

  • Active comparator
    Arm 2

    Smoking cessation with written materials + LDCT lung cancer screening

    Other: low-dose computed tomography · Other: Written materials for smoking cessation

  • Active comparator
    Arm 3

    Smoking cessation with a smartphone application without LDCT lung cancer screening

    Other: Smartphone application

Interventions

  • OtherSmartphone application

    Suunta smartphone application for smoking cessation

  • Otherlow-dose computed tomography

    Low-dose computed tomography based screening for lung cancer

  • OtherWritten materials for smoking cessation

    Written materials for smoking cessation

06

What researchers measure

Primary outcomes

  1. Rate of smoking cessation

    The percentage of participants who have quitted smoking between the study arms 1 vs. 2

    Time frame: three months

Secondary outcomes

  1. Rate of smoking cessation

    The percentage of participants who have quitted smoking between all the study arms

    Time frame: Three months

  2. Rate of smoking cessation

    The percentage of participants who have quitted smoking between all the study arms

    Time frame: 12 and 24 months

  3. Rate of long-term smoking cessation

    The percentage of participants who have had abstinence of smoking for at least six months

    Time frame: 12 and 24 moths

  4. LDCT findings

    The percentage of LDCT negative, indetermined, and positive findings by screening round

    Time frame: baseline and 24 months

  5. Sensitivity and specificity of LDCT screening examination

    Sensitivity and specificity of LDCT screening examination for lung cancer detection (arms 1\&2 vs. 3)

    Time frame: 24 months, 36 months, and 10 years

  6. Lung cancer incidence

    Lung cancer incidence (stage specific) (arms 1\&2 vs. 3)

    Time frame: 24 months, 36 months, and 10 years

  7. Frequency of self-reported smoking cessation verified with CO measurement

    Frequency of self-reported smoking cessation verified with CO measurement

    Time frame: 24 months

07

Study locations

1 of 5 sites recruiting
08

References and documents

Publications

  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PubMed 21714641 ↗
  • de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29. PubMed 31995683 ↗
  • Iivanainen S, Kurtti A, Wichmann V, Andersen H, Jekunen A, Kaarteenaho R, Vasankari T, Koivunen JP. Smartphone application versus written material for smoking reduction and cessation in individuals undergoing low-dose computed tomography (LDCT) screening for lung cancer: a phase II open-label randomised controlled trial. Lancet Reg Health Eur. 2024 May 25;42:100946. doi: 10.1016/j.lanepe.2024.100946. eCollection 2024 Jul. PubMed 39070744 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results reported in this article will be shared.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: The data will be available beginning 6 months after publication and ending 3 years thereafter.

Access criteria: Data will be shared with qualified researchers who submit a methodologically sound proposal for analyses that align with the original study aims. Proposals should be submitted to the corresponding author. Access will require a data use agreement.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07331519
Lead sponsor
Oulu University Hospital
Collaborators
Finnish Cancer Society
Responsible party
Sponsor
First posted
Jan 12, 2026
Start date
Feb 2, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Aug 31, 2036 (estimated)
Last update
Feb 6, 2026

Study contacts

Jussi P Koivunen, MD, PhD
Contact
jussi.koivunen@pohde.fi
+358504182666
Sanna Iivanainen, MD, PhD
Contact
sanna.iivanainen@pohde.fi
+358504178347
Tytti Särkeälä, PhD
study director · Finnish Cancer Society

Oversight

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

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