Pulmonary Nodule, SolitaryNCT07322796
Smoking Cessation Before Bronchoscopy or CT-guided Puncture
An observational study of Pulmonary Nodule, Solitary and Smoking Behaviors, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Nicotine is the most common preventable cause of death and is responsible for over seven million deaths worldwide. If current trends continue, tobacco will kill more than eight million people worldwide every year by 2030. Smoking tobacco products is the most important risk factor for the development of lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary, Smoking Behaviors
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2026to 31 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Active smokers by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule
Who may be able to join
- The patient is an active smoker by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule
Who cannot join
- Current or past medically relevant illness or treatment that could affect the evaluability of the study.
- Expected lack of willingness to actively participate in study-related measures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Maria Dr. Aetou, Dr., maetou@ukaachen.de
About this study
Official title: Smoking Cessation Before Intervention in Patients With Pulmonary Nodules Requiring Further Diagnosis
Nicotine is the most common preventable cause of death and is responsible for over seven million deaths worldwide. If current trends continue, tobacco will kill more than eight million people worldwide every year by 2030. Smoking tobacco products is the most important risk factor for the development of lung cancer. Passive smoking is also a major cause of lung cancer. Since July 2024, smokers and former smokers have been able to receive a low-radiation CT scan under certain conditions to detect lung cancer at an early stage. It is therefore to be expected that the number of diagnoses of pulmonary lesions or nodules will increase in the near future. The risk of developing and dying from tobacco-related diseases is reduced once nicotine cessation begins. Screening all patients for tobacco use, e-cigarette use, and providing behavioral counseling and pharmacotherapy to quit smoking are among the most valuable preventive services we can offer in healthcare.
Nicotine dependence can be estimated using the so-called Fagerström test. An additional evaluation of nicotine behavior can be carried out by testing cotinine in urine, a method that is used, for example, in the listing for lung transplantation. Cotinine is a degradation product of nicotine that can be detected in the urine of smokers and passive smokers. Cotinine levels in urine depend on the frequency and quantity of nicotine consumption. The half-life of cotinine is 16 to 22 hours, which means that half of the cotinine is excreted from the body after this time. Another marker that can be used as a measure of tobacco consumption is carboxyhaemoglobin (COHb). This is hemoglobin with carbon monoxide at the binding site for oxygen. The reference range for carboxyhaemoglobin is 0.4 - 1.6 %. In smokers, values of 3-10 % are still considered normal.
Read more
In our department, the smoking status of patients is assessed upon first contact. Support options for smoking cessation are offered and, upon request, initiated. Previous studies have shown that smoking is a risk factor for complications after thoracic surgical procedures and that patients who underwent thoracic surgery quit smoking almost twice as often compared to patients who did not undergo surgery. However, to the best of our knowledge, there is currently no study regarding smoking cessation before intervention in patients with nodules needing clarification (bronchoscopy or CT-guided puncture).
Therefore, the aim of the study is to support and monitor smoking cessation before intervention in patients with nodules needing further diagnosis (bronchoscopy or CT-guided puncture).
Read the detailed description
Patients who present to our outpatient clinic for the evaluation of a concerning round lesion (V1) are asked during the medical history taking whether they currently smoke. If the question is answered affirmatively, patients are urgently advised to quit smoking immediately. Support options for smoking cessation are presented, and if desired, a connection to a smoking cessation counseling program of the Federal Institute for Public Health ('rauchfrei ticket') is established. Furthermore, nicotine dependence is assessed using the Fagerström test, while COHb is determined through blood gas analysis and cotinine is measured in urine. During the planned result discussion (V2) after the inpatient stay for histological confirmation (either via bronchoscopy or CT-guided puncture), patients are asked if they have quit smoking and COHb and cotinine are measured again. After 3 months (V3), these values will be measured conclusively. In addition, the following data will be collected and documented from the patients: age, gender, height, weight, current medication, other illnesses, and current body plethysmography. Participation in the study does not change the course of the patients' stay in our clinic.
- Conditions
- Pulmonary Nodule, Solitary, Smoking Behaviors
- Keywords
- smoking, smoking cessation, pulmonary nodules
- Medical subject headings
- Solitary Pulmonary Nodule, Smoking, Smoking Cessation, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessated | Patients who have stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated. | |
| Smoking not cessated | Patients who have not stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Patients who visit our outpatient clinic for the purpose of investigating a pulmonary lesion that requires clarification, are asked during the medical history if they are active smokers. If the answer is yes, patients are strongly advised to stop smoking immediately. Support options for smoking cessation are presented and, if desired, a connection to a smoking cessation counseling program offered by the Federal Institute for Public Health ("rauchfrei ticket") is established. In addition, nicotine dependence is assessed using the Fagerström test, COHb is determined by blood gas analysis, and cotinine is determined in urine. The same parameters will bei measured after 2-4 weeks and 3 months.
As primary outcome measure, the number of patients who are likely to be smoke-free at the end of the observation period will be assessed.
Measured: From enrollment to the end of the observation period 3 months later
Secondary outcomes (4)
Analysis of demographic data
Age, gender, height, weight, comorbidities, medication
Measured: Within 3 months
Spirometry (Lungfunction)
During the study period, the spirometry of the enrolled patients will be assessed. The parameters that are included are the following:
- peak expiratory flow (PEF) in L/s
- mean expiratory flow at 75% of vital capacity (MEF75) in L/s
- mean expiratory flow at 50% of vital capacity (MEF50) in L/s
- mean expiratory flow at 25% of vital capacity (MEF25) in L/s
- forced expiratory volume in 1 second (FEV1) in L
Measured: Within 3 Months
Bodyplethysmography (Lungfunction)
During the study period, the bodyplethysmography of the enrolled patients will be assessed. The parameters that are included are the following
- total lung capacity (TLC) in L
- vital capacity (VC) in L
- residual volume (RV) in L
- functional residual capacity assessed using plethysmography FRCpleth) in L
- DLCO/VA [mmol/(min*kPa*L]
Measured: Within 3 months
Diffusing capacity (lungfunction)
During the study period, the diffusing capacity of the enrolled patients will be assessed. The parameters that are included are the following
- diffusing capacity of the lungs for carbon monoxide/aveolarventilation (DLCO/VA) in [mmol/(min*kPa*L]
Measured: Within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Nodule, SolitaryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Spießhöfer, RWTH Aachen University
- Investigators
- Michael Dreher Univ.-Prof. Dr.med, Study director, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322796
- Sponsor's protocol ID
- 25-251
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mustoe MM, Clark JM, Huynh TT, Tong EK, Wolf TP, Brown LM, Cooke DT. Engagement and Effectiveness of a Smoking Cessation Quitline Intervention in a Thoracic Surgery Clinic. JAMA Surg. 2020 Sep 1;155(9):816-822. doi: 10.1001/jamasurg.2020.1915.
PubMed 32609348Wong C, Mohamad Asfia SKB, Myles PS, Cunningham J, Greenhalgh EM, Dean E, Doncovio S, Briggs L, Graves N, McCaffrey N. Smoking and Complications After Cancer Surgery: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2025 Mar 3;8(3):e250295. doi: 10.1001/jamanetworkopen.2025.0295.
PubMed 40053349Marrufo AS, Kozower BD, Tancredi DJ, Nuno M, Cooke DT, Pollock BH, Romano PS, Brown LM. Thoracic Surgeons' Beliefs and Practices on Smoking Cessation Before Lung Resection. Ann Thorac Surg. 2019 May;107(5):1494-1499. doi: 10.1016/j.athoracsur.2018.11.055. Epub 2018 Dec 23.
PubMed 30586576Patnode CD, Henderson JT, Coppola EL, Melnikow J, Durbin S, Thomas RG. Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 Jan 19;325(3):280-298. doi: 10.1001/jama.2020.23541.
PubMed 33464342Maciosek MV, Coffield AB, Edwards NM, Flottemesch TJ, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: results of a systematic review and analysis. Am J Prev Med. 2006 Jul;31(1):52-61. doi: 10.1016/j.amepre.2006.03.012.
PubMed 16777543Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.
PubMed 23343063Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.
PubMed 15710956Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.
PubMed 15213107
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Before Intervention in Patients With Pulmonary Nodules Requiring Further Diagnosis
- ClinicalTrials.gov ID
- NCT07322796
- Acronym / sponsor ID
- 25-251
- Conditions
- Pulmonary Nodule, Solitary, Smoking Behaviors
- Keywords
- smoking, smoking cessation, pulmonary nodules
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 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.
Nicotine is the most common preventable cause of death and is responsible for over seven million deaths worldwide. If current trends continue, tobacco will kill more than eight million people worldwide every year by 2030. Smoking tobacco products is the most important risk factor for the development of lung cancer. Passive smoking is also a major cause of lung cancer. Since July 2024, smokers and former smokers have been able to receive a low-radiation CT scan under certain conditions to detect lung cancer at an early stage. It is therefore to be expected that the number of diagnoses of pulmonary lesions or nodules will increase in the near future. The risk of developing and dying from tobacco-related diseases is reduced once nicotine cessation begins. Screening all patients for tobacco use, e-cigarette use, and providing behavioral counseling and pharmacotherapy to quit smoking are among the most valuable preventive services we can offer in healthcare.
Nicotine dependence can be estimated using the so-called Fagerström test. An additional evaluation of nicotine behavior can be carried out by testing cotinine in urine, a method that is used, for example, in the listing for lung transplantation. Cotinine is a degradation product of nicotine that can be detected in the urine of smokers and passive smokers. Cotinine levels in urine depend on the frequency and quantity of nicotine consumption. The half-life of cotinine is 16 to 22 hours, which means that half of the cotinine is excreted from the body after this time. Another marker that can be used as a measure of tobacco consumption is carboxyhaemoglobin (COHb). This is hemoglobin with carbon monoxide at the binding site for oxygen. The reference range for carboxyhaemoglobin is 0.4 - 1.6 %. In smokers, values of 3-10 % are still considered normal.
In our department, the smoking status of patients is assessed upon first contact. Support options for smoking cessation are offered and, upon request, initiated. Previous studies have shown that smoking is a risk factor for complications after thoracic surgical procedures and that patients who underwent thoracic surgery quit smoking almost twice as often compared to patients who did not undergo surgery. However, to the best of our knowledge, there is currently no study regarding smoking cessation before intervention in patients with nodules needing clarification (bronchoscopy or CT-guided puncture).
Therefore, the aim of the study is to support and monitor smoking cessation before intervention in patients with nodules needing further diagnosis (bronchoscopy or CT-guided puncture).
Detailed description
Patients who present to our outpatient clinic for the evaluation of a concerning round lesion (V1) are asked during the medical history taking whether they currently smoke. If the question is answered affirmatively, patients are urgently advised to quit smoking immediately. Support options for smoking cessation are presented, and if desired, a connection to a smoking cessation counseling program of the Federal Institute for Public Health ('rauchfrei ticket') is established. Furthermore, nicotine dependence is assessed using the Fagerström test, while COHb is determined through blood gas analysis and cotinine is measured in urine. During the planned result discussion (V2) after the inpatient stay for histological confirmation (either via bronchoscopy or CT-guided puncture), patients are asked if they have quit smoking and COHb and cotinine are measured again. After 3 months (V3), these values will be measured conclusively. In addition, the following data will be collected and documented from the patients: age, gender, height, weight, current medication, other illnesses, and current body plethysmography. Participation in the study does not change the course of the patients' stay in our clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessated | – | –Patients who have stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated. |
| Smoking not cessated | – | –Patients who have not stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active smokers by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule
Key inclusion criteria (1 listed)
- The patient is an active smoker by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule
Key exclusion criteria (2 listed)
- Current or past medically relevant illness or treatment that could affect the evaluability of the study.
- Expected lack of willingness to actively participate in study-related measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Smoking Cessation
Time frame: From enrollment to the end of the observation period 3 months later
Patients who visit our outpatient clinic for the purpose of investigating a pulmonary lesion that requires clarification, are asked during the medical history if they are active smokers. If the answer is yes, patients are strongly advised to stop smoking immediately. Support options for smoking cessation are presented and, if desired, a connection to a smoking cessation counseling program offered by the Federal Institute for Public Health ("rauchfrei ticket") is established. In addition, nicotine dependence is assessed using the Fagerström test, COHb is determined by blood gas analysis, and cotinine is determined in urine. The same parameters will bei measured after 2-4 weeks and 3 months. As primary outcome measure, the number of patients who are likely to be smoke-free at the end of the observation period will be assessed.
4 secondary outcomes
Analysis of demographic data
Time frame: Within 3 months
Spirometry (Lungfunction)
Time frame: Within 3 Months
Bodyplethysmography (Lungfunction)
Time frame: Within 3 months
Diffusing capacity (lungfunction)
Time frame: Within 3 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 28 Jan 2026.
- Background: PubMed 32609348Mustoe MM, Clark JM, Huynh TT, Tong EK, Wolf TP, Brown LM, Cooke DT. Engagement and Effectiveness of a Smoking Cessation Quitline Intervention in a Thoracic Surgery Clinic. JAMA Surg. 2020 Sep 1;155(9):816-822. doi: 10.1001/jamasurg.2020.1915.
- Background: PubMed 40053349Wong C, Mohamad Asfia SKB, Myles PS, Cunningham J, Greenhalgh EM, Dean E, Doncovio S, Briggs L, Graves N, McCaffrey N. Smoking and Complications After Cancer Surgery: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2025 Mar 3;8(3):e250295. doi: 10.1001/jamanetworkopen.2025.0295.
- Background: PubMed 30586576Marrufo AS, Kozower BD, Tancredi DJ, Nuno M, Cooke DT, Pollock BH, Romano PS, Brown LM. Thoracic Surgeons' Beliefs and Practices on Smoking Cessation Before Lung Resection. Ann Thorac Surg. 2019 May;107(5):1494-1499. doi: 10.1016/j.athoracsur.2018.11.055. Epub 2018 Dec 23.
- Background: PubMed 33464342Patnode CD, Henderson JT, Coppola EL, Melnikow J, Durbin S, Thomas RG. Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 Jan 19;325(3):280-298. doi: 10.1001/jama.2020.23541.
- Background: PubMed 16777543Maciosek MV, Coffield AB, Edwards NM, Flottemesch TJ, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: results of a systematic review and analysis. Am J Prev Med. 2006 Jul;31(1):52-61. doi: 10.1016/j.amepre.2006.03.012.
- Background: PubMed 23343063Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.
- Background: PubMed 15710956Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.
- Background: PubMed 15213107Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.
- Individual participant dataSharing planned: No
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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.
Michael Dreher Univ.-Prof. Dr.med study director
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Solitary and Smoking Behaviors, run by RWTH Aachen University at 1 site in Germany.
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 1 inclusion and 2 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Maria Aetou Dr.med (00492418088763, maetou@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: From enrollment to the end of the observation period 3 months later). 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 NCT07322796, which also lists 8 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 28 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.