biobanking
Biologicalblood draw at each time point
NCT Number: NCT07042867
Interventional study with minimal risks and constraints, involving annual assessment of the prevalence and incidence of lung cancer using low-dose contrast-free thoracic CT scans, immunological, inflammatory, metabolic, blood nucleic acid and digestive microbiota profiles; systematic proposal of smoking cessation for active smokers, or assistance in maintaining cessation This is a prospective validation study of risk stratification tools still under development.
The results of this study will be used to design medical devices (software integrating risk stratification tools), which will then be evaluated as part of subsequent Clinical Investigations.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 :
All Groups:
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
All Groups
blood draw at each time point
low dose lung scan will be performed at each timepoint
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Time frame: 30 months
Contact information is provided by the study sponsor or research team.
Assistance Publique Hopitaux De Marseille
Other
Acronym: LUCA-pi COHORT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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