Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorAssistance Publique Hopitaux De Marseille

About this trial

Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1- All PREVALUNG or PREVALUNG ETOILE participants

2- Active or former smokers who have smoked daily for at least 10 years and have either atheromatous disease (coronary, lower limb, supra-aortic trunk, aortic, visceral or upper limb arteries) or a moderate or high coronary calcium score*, **.

Age 45- 75 years and

Medical follow-up for smoking-related atheromatous pathology and

Disqualifiers

cancer history < 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 unmeasurable PSA)

symptoms of lung cancer (involuntary weight loss > 7 kg in 1 year, hemoptysis)

known history of pulmonary nodule requiring specialized follow-up

history of pulmonary fibrosis or pulmonary hypertension

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sampling

    Diagnostic test

    blood collection

  • stool collection

    Diagnostic test

    stool collection

  • low dose CT scan

    Radiation

    low dose CT scan evaluation

Treatment groups

750 Participants
are divided into 1 treatment group
Group A: all patientsOther 3 interventions

Trial outcomes

Primary outcomes

1

biomarker group validation

Sensitivity and specificity of each biomarker

Time frame
51 months

Secondary outcomes

1

Describe changes in biomarkers over time

reporting the value of each biomarker at each patient's visit to visit

Time frame
51 months
2

Describe and compare biomarkers according to clinical characteristics of participants

Value of each biomarker according to the clinical characteristics of participants

Time frame
51 months
3

Describe changes in quality of life over time

Quality of life (SF-12 score) at each visit.

Time frame
51 months
4

Describe changes in smoking habits over time

Smoking cessation rate achieved (partial and/or total) among participants active smokers

Time frame
51 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.