An observational study in Pulmonary Nodule, Solitary and Smoking Behaviors, sponsored by RWTH Aachen University. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by RWTH Aachen University · Observational
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).
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.
93 studies on the registry are indexed under Solitary Pulmonary Nodule; 20 are open to participants now.
This study's planned enrollment of 25 is below the median of 401 across 45 observational studies indexed under Solitary Pulmonary Nodule.
Browse Solitary Pulmonary Nodule studies →RWTH Aachen University is the lead sponsor of 230 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Active smokers by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule
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.
Exclusion Criteria:
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.
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.
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.
Time frame: From enrollment to the end of the observation period 3 months later
Analysis of demographic data
Age, gender, height, weight, comorbidities, medication
Time frame: 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
Time frame: 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 \[mmol/(min\*kPa\*L\]
Time frame: 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 \[mmol/(min\*kPa\*L\]
Time frame: Within 3 months
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Aug 2027, 19 months after the start.
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