Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT07042867
Eligibility Criteria:
Inclusion Criteria:
Group A:
CI 1- Age \> 18 years AND CI2a- Person eligible for screening with a nodule or lung mass with no indication of reassessment by CT scan before the next round of screening, as recommended by the multidisciplinary consultation meeting OR CI2b- Person not eligible for screening with a nodule or lung mass with an indication for reassessment by CT scan without immediate diagnostic workup (PET scan, biopsy, surgery) as determined by the multidisciplinary consultation meeting.
Group B CI1- Age \> 18 years AND CI2- Indication for biopsy or surgical excision for diagnostic and therapeutic purposes proposed in a multidisciplinary consultation meeting.
Group C CI1a- Age 40 - 75 and daily smoking for at least 20 years initiated before age 15 OR CI1b- Age 50 - 75 and passive smoking for at least 20 years in a closed environment (family or workplace) OR CI1c- Age 50 - 75 and smoking 10 cig/d for 30 years or 15 cig/d for 25 years or 20 pack-years with no withdrawal period OR
CI1d- Age 50 - 75 and daily smoking for at least 10 years combined with at least one other lung cancer risk factor from among :
* Self-reported daily passive smoking for \> 10 years (smokers at home or in enclosed environments)
* Self-reported exposure to a lung carcinogen: Radon, coal smoke, soot, diesel, nickel, beryllium, arsenic, cadmium, asbestos
* 1st-degree family history of lung cancer
* Personal history of tobacco-related disease, including atheromatous cardiovascular disease, COPD or emphysema, cancer not monitored by chest imaging
* weekly use of cannabis (joints) for 10 years
All Groups:
* Have signed an informed consent form
* Affiliated with or benefiting from a social security scheme
* Male or female
Exclusion Criteria:
Goups A and B Contraindication to lung biopsy or thoracic surgery for diagnostic or therapeutic purposes
Group C Eligible for lung cancer screening according to INCa\* criteria
* Previous cancer \< 5 years (except carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin, non-invasive urothelial carcinoma treated for curative purposes without CT lung surveillance, prostate cancer with undiagnosable PSA)
* Symptoms of lung cancer (involuntary weight loss \> 10% of usual weight in 1 year, hemoptysis)
* Known history of pulmonary nodule requiring specialized follow-up
* History of pulmonary fibrosis or pulmonary hypertension
* Active pulmonary parenchymal infection
* Severe cardiac or respiratory insufficiency (rest dyspnea)
* Performance status (WHO) 2, 3 or 4
All Groups
* patient privé de liberté
* patient sous tutelle ou curatelle
* femmes enceintes ou allaitantes
* patient dans l'incapacité d'effectuer le suivi de 30 mois
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07042867
Study Brief:
Protocol Section:
NCT07042867