Smoking CessationISC-LDCTNCT07331519
Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer
A study testing Smartphone application, low-dose computed tomography and Written materials for smoking cessation in people with Smoking Cessation, run by Oulu University Hospital at 5 sites in Finland.
Trial summary
The study investigates effectiveness of different smoking cessation methods and low-dose CT based lung cancer screening Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smartphone application, low-dose computed tomography and Written materials for smoking cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 5 sitesFinland
- Study dates
- 2 Feb 2026to 31 Aug 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Age between 50-74
- 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)
- Access to a smartphone (iPhone or Android)
Who cannot join
- Current or past melanoma, lung, renal or breast cancer
- A chest CT examination less than one year before inclusion
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- No access to a smartphone (iPhone or Android)
- Participant is unwilling or unable to comply with treatment and trial instructions
- Any condition that study investigators consider an impediment to safe trial participation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Finland5 sites, 5 recruiting
- Not yet recruiting
Helsinki University Hospital
Helsinki
Ilkka Ilonen, MD, PhD, +358504272280, ilkka.ilonen@hus.fi
- Recruiting
Oulu University Hospital
Oulu
Jussi P Koivunen, MD, PhD, +358504182666
- Not yet recruiting
Tampere University Hospital
Tampere
Hannele Hasala, MD, PhD, +358444735254, hannele.hasala@pirha.fi
- Not yet recruiting
Turku University Hospital
Turku
Maria Silvoniemi, MD, PhD, +35823138709
- Not yet recruiting
Vaasa Central Hospital
Vaasa
Heidi Andersen, MD, PhD, +358401763563, heidi.andersen@ovph.fi
About this study
Official title: Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer - a Randomized Study
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.
- Conditions
- Smoking Cessation
- Being tested
- Smartphone application, low-dose computed tomography, Written materials for smoking cessation
- Keywords
- smoking cessation, lung cancer, low-dose CT, lung cancer screening
- Medical subject headings
- Smoking Cessation, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone applicationOther
Suunta smartphone application for smoking cessation
low-dose computed tomographyOther
Low-dose computed tomography based screening for lung cancer
Written materials for smoking cessationOther
Written materials for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Smoking cessation with a smartphone application + LDCT lung cancer screening Receives: Other: Smartphone application; Other: low-dose computed tomography |
| Arm 2 | Active comparator | Smoking cessation with written materials + LDCT lung cancer screening Receives: Other: low-dose computed tomography; Other: Written materials for smoking cessation |
| Arm 3 | Active comparator | Smoking cessation with a smartphone application without LDCT lung cancer screening Receives: Other: Smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of smoking cessation
The percentage of participants who have quitted smoking between the study arms 1 vs. 2
Measured: three months
Secondary outcomes (7)
Rate of smoking cessation
The percentage of participants who have quitted smoking between all the study arms
Measured: Three months
Rate of smoking cessation
The percentage of participants who have quitted smoking between all the study arms
Measured: 12 and 24 months
Rate of long-term smoking cessation
The percentage of participants who have had abstinence of smoking for at least six months
Measured: 12 and 24 moths
LDCT findings
The percentage of LDCT negative, indetermined, and positive findings by screening round
Measured: baseline and 24 months
Sensitivity and specificity of LDCT screening examination
Sensitivity and specificity of LDCT screening examination for lung cancer detection (arms 1\&2 vs. 3)
Measured: 24 months, 36 months, and 10 years
Lung cancer incidence
Lung cancer incidence (stage specific) (arms 1\&2 vs. 3)
Measured: 24 months, 36 months, and 10 years
Frequency of self-reported smoking cessation verified with CO measurement
Frequency of self-reported smoking cessation verified with CO measurement
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start2 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Tytti Särkeälä, PhD, Study director, Finnish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331519
- Sponsor's protocol ID
- EETMK 15/2025
- Other IDs
- EETMK 15/2025
- Acronym
- ISC-LDCT
- Status last verified
- Feb 2025
- First submitted
- 29 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this article will be shared.
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 21714641de 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 31995683Iivanainen 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer - a Randomized Study
- ClinicalTrials.gov ID
- NCT07331519
- Acronym / sponsor ID
- ISC-LDCT / EETMK 15/2025
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, lung cancer, low-dose CT, lung cancer screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Finnish Cancer Society
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2036 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates effectiveness of different smoking cessation methods and low-dose CT based lung cancer screening
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Smartphone application, Other: low-dose computed tomographySmoking cessation with a smartphone application + LDCT lung cancer screening |
| Arm 2 | Active comparator | Other: low-dose computed tomography, Other: Written materials for smoking cessationSmoking cessation with written materials + LDCT lung cancer screening |
| Arm 3 | Active comparator | Other: Smartphone applicationSmoking cessation with a smartphone application without LDCT lung cancer screening |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide written informed consent
- Age between 50-74
- 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)
- Access to a smartphone (iPhone or Android)
Key exclusion criteria (6 listed)
- Current or past melanoma, lung, renal or breast cancer
- A chest CT examination less than one year before inclusion
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- No access to a smartphone (iPhone or Android)
- Participant is unwilling or unable to comply with treatment and trial instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone applicationSuunta smartphone application for smoking cessation | Other | Arm 1, Arm 3 |
| low-dose computed tomographyLow-dose computed tomography based screening for lung cancer | Other | Arm 1, Arm 2 |
| Written materials for smoking cessationWritten materials for smoking cessation | Other | Arm 2 |
Primary outcome
Rate of smoking cessation
Time frame: three months
The percentage of participants who have quitted smoking between the study arms 1 vs. 2
7 secondary outcomes
Rate of smoking cessation
Time frame: Three months
Rate of smoking cessation
Time frame: 12 and 24 months
Rate of long-term smoking cessation
Time frame: 12 and 24 moths
LDCT findings
Time frame: baseline and 24 months
Sensitivity and specificity of LDCT screening examination
Time frame: 24 months, 36 months, and 10 years
Lung cancer incidence
Time frame: 24 months, 36 months, and 10 years
Frequency of self-reported smoking cessation verified with CO measurement
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 21714641National 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.
- Results publication: PubMed 31995683de 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.
- Results publication: PubMed 39070744Iivanainen 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this article will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tytti Särkeälä, PhD study director
Finnish Cancer Society
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application, low-dose computed tomography and Written materials for smoking cessation in people with Smoking Cessation, run by Oulu University Hospital at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jussi P Koivunen, MD, PhD (+358504182666, jussi.koivunen@pohde.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of smoking cessation (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07331519, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.