Lung Cancer (Diagnosis)LUCA-pi COHORTNCT07042867
Prospective Multicenter Cohort Study for the Development and Evaluation of Risk Stratification Tools for Lung Cancers and Their Postoperative Recurrences Using Multimodal Clinical, Radiological, Tissue and Longitudinal Biological Phenotyping Among People at Risk of Lung Cancer
A study testing biobanking and low dose scan in people with Lung Cancer (Diagnosis), run by Assistance Publique Hopitaux De Marseille.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- biobanking and low dose scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Jan 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Lung Cancer (Diagnosis)
- Being tested
- biobanking, low dose scan
- Keywords
- lung cancer, lung nodules, prevention, dignosis, low dose scan, biomarkers
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biobankingBiological
blood draw at each time point
low dose scanRadiation
low dose lung scan will be performed at each timepoint
| Study group | Role | What they receive |
|---|---|---|
| Group A: patients with a nodule or lung mass identified on CT scan, with no indication of an immedi | Other | patients with a nodule or lung mass identified on CT scan, with no indication of an immediate diagnostic workup Receives: Biological: biobanking; Radiation: low dose scan |
| Group B: cohort of patients with a nodule or lung mass identified on CT with an indication for biops | Other | cohort of patients with a nodule or lung mass identified on CT with an indication for biopsy or excision surgery Receives: Biological: biobanking; Radiation: low dose scan |
| Group C: Individuals with at least one risk factor for lung cancer and no prior lung imaging, but no | Other | Individuals with at least one risk factor for lung cancer and no prior lung imaging, but not eligible for lung cancer screening according to INCa criteria. Receives: Biological: biobanking; Radiation: low dose scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the radiomics algorithm for characterizing benign vs. malignant lung lesions.
Measured: 30 months
Secondary outcomes (6)
Sensitivity and specificity of minimal biological panel based on markers of inflammation, immunity, blood metabolism and stool metagenomics for characterization of benign vs. malignant lung lesions.
Measured: 30 months
Sensitivity and specificity of new biomarkers including specific antibodies and circulating nucleic acids for characterization of benign vs. malignant lung lesions.
Measured: 30 months
Sensitivity and specificity of a patho-radiomic-based algorithm quantifying the risk of recurrence of operated lung cancers.
Measured: 30 months
Sensitivity and specificity of minimal and novel biomarker panels for the prediction of postoperative lung cancer recurrence.
Measured: 30 months
Description of biomarker panels among people not eligible for lung cancer screening.
Measured: 30 months
Change over time in biomarkers overall, then in each of the following subgroups: - people undergoing lung cancer surgery - smoking cessation patients - people with an incident diagnosis of lung cancer
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Boulate, Professor of Medicine, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042867
- Sponsor's protocol ID
- 2024-A02828-39
- Acronym
- LUCA-pi COHORT
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Cohort Study for the Development and Evaluation of Risk Stratification Tools for Lung Cancers and Their Postoperative Recurrences Using Multimodal Clinical, Radiological, Tissue and Longitudinal Biological Phenotyping Among People at Risk of Lung Cancer
- ClinicalTrials.gov ID
- NCT07042867
- Acronym / sponsor ID
- LUCA-pi COHORT / 2024-A02828-39
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- lung cancer, lung nodules, prevention, dignosis, low dose scan, biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 29 Jun 2025 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: patients with a nodule or lung mass identified on CT scan, with no indication of an immedi | Other | Biological: biobanking, Radiation: low dose scanpatients with a nodule or lung mass identified on CT scan, with no indication of an immediate diagnostic workup |
| Group B: cohort of patients with a nodule or lung mass identified on CT with an indication for biops | Other | Biological: biobanking, Radiation: low dose scancohort of patients with a nodule or lung mass identified on CT with an indication for biopsy or excision surgery |
| Group C: Individuals with at least one risk factor for lung cancer and no prior lung imaging, but no | Other | Biological: biobanking, Radiation: low dose scanIndividuals with at least one risk factor for lung cancer and no prior lung imaging, but not eligible for lung cancer screening according to INCa criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| biobankingblood draw at each time point | Biological | Group A: patients with a nodule or lung mass identified on CT scan, with no indication of an immedi, Group B: cohort of patients with a nodule or lung mass identified on CT with an indication for biops, Group C: Individuals with at least one risk factor for lung cancer and no prior lung imaging, but no |
| low dose scanlow dose lung scan will be performed at each timepoint | Radiation | Group A: patients with a nodule or lung mass identified on CT scan, with no indication of an immedi, Group B: cohort of patients with a nodule or lung mass identified on CT with an indication for biops, Group C: Individuals with at least one risk factor for lung cancer and no prior lung imaging, but no |
Primary outcome
Sensitivity and specificity of the radiomics algorithm for characterizing benign vs. malignant lung lesions.
Time frame: 30 months
6 secondary outcomes
Sensitivity and specificity of minimal biological panel based on markers of inflammation, immunity, blood metabolism and stool metagenomics for characterization of benign vs. malignant lung lesions.
Time frame: 30 months
Sensitivity and specificity of new biomarkers including specific antibodies and circulating nucleic acids for characterization of benign vs. malignant lung lesions.
Time frame: 30 months
Sensitivity and specificity of a patho-radiomic-based algorithm quantifying the risk of recurrence of operated lung cancers.
Time frame: 30 months
Sensitivity and specificity of minimal and novel biomarker panels for the prediction of postoperative lung cancer recurrence.
Time frame: 30 months
Description of biomarker panels among people not eligible for lung cancer screening.
Time frame: 30 months
Change over time in biomarkers overall, then in each of the following subgroups: - people undergoing lung cancer surgery - smoking cessation patients - people with an incident diagnosis of lung cancer
Time frame: 30 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 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
David Boulate, Professor of Medicine principal investigator
Assistance Publique Hopitaux De Marseille
Questions about this trial
What is this clinical trial studying?
A study testing biobanking and low dose scan in people with Lung Cancer (Diagnosis), run by Assistance Publique Hopitaux De Marseille.
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 14 inclusion and 14 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: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 David Boulate, Professor (+33 491966018, david.boulate@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the radiomics algorithm for characterizing benign vs. malignant lung lesions. (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.