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

NCT06387017 | Recruiting

• 1 other identifier: RCAPHM22_0411
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking-related Pathology; Atheroma; Non-progressive Cancer > 5 Years; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• biomarker group validation

  Sensitivity and specificity of each biomarker

  51 months

Secondary Outcomes (8)

• Describe changes in biomarkers over time

  51 months

• Describe and compare biomarkers according to clinical characteristics of participants

  51 months

• Describe changes in quality of life over time

  51 months

• Describe changes in smoking habits over time

  51 months

• Describe changes in anxiety over time

  51 months

Study Arms (1)

all patients

OTHER

Diagnostic Test: blood sampling; Diagnostic Test: stool collection; Radiation: low dose CT scan

Interventions

blood sampling DIAGNOSTIC_TEST

blood collection

all patients

stool collection DIAGNOSTIC_TEST

stool collection

all patients

low dose CT scan RADIATION

low dose CT scan evaluation

all patients

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All PREVALUNG or PREVALUNG ETOILE participants
• 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
• daily smoking for at least 10 years prior to disease (for smoking, there are no quantitative criteria or withdrawal times)
• visual coronary calcium score quantified by a radiologist on a chest CT scan.
• Age 45- 75 and
• Medical follow-up for a smoking-related pathology:
• chronic obstructive pulmonary disease / emphysema, or
• history of non-progressive cancer \> 5 years, including ENT, lung, breast, cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia.
• and
• \- daily smoking for at least 10 years prior to the disease (for smoking, there are no quantitative criteria or withdrawal periods).
• Age 55 - 74
• Cumulative smoking ≥ 30 pack-years
• active or weaned for less than 15 years Or

You may not qualify if:

• 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
• active pulmonary parenchymal infection
• severe cardiac or respiratory insufficiency (rest dyspnea)
• performance status (WHO) 2, 3 or 4
• patient not affiliated to the social security system (beneficiary or beneficiary's beneficiary)
• patient deprived of liberty
• patients under guardianship or trusteeship
• pregnant or breast-feeding women

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Plaque, Atherosclerotic; Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mathilde LEFEVRE

  ASSISTANCEPUBLIQUE HOPTAUX DE MARSEILLE

  STUDY DIRECTOR

Central Study Contacts

Amandine ROLLAND-BRUN

CONTACT

491381245; amandine.rolland@ap-hm.fr

David BOULATE

CONTACT

david.boulate@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 26, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

FR (1)