RecruitingNot ApplicableNCT05306912

Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules

Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules (Cancer Or Benign Endoscopy) (KOBE)

Sponsor

University Hospital, Toulouse

Enrollment

60 participants

Start Date

Apr 8, 2022

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Lung; Node

Summary

Lung cancer screening is based on low dose CT scan (LDCT), a highly sensitive but poorly specific tool. Complementary specific approaches are thus strongly needed, among which cell-free DNA (cfDNA) genotyping has been proven highly specific but of low sensitivity (25 to 50% for stage I diseases) due to inconstant tumor shed. Tumor biopsy is thus often required and radial endobronchial ultrasound (rEBUS) bronchoscopy is a minimally invasive approach (\<3% complications) but of limited sensitivity in cases of nodules \< 20 mm. The investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether fluid collected during a lung bronchoscopy procedure can be used to detect cancer-related genetic changes in small lung nodules (spots on the lung). Researchers hope this could improve how lung nodules are diagnosed without needing more invasive procedures. **You may be eligible if...** - You are scheduled for a bronchoscopy (a procedure to look inside the airways) for 1–3 small lung nodules that are 20mm or smaller - You have a general health status good enough to undergo the procedure (WHO Performance Status 0–3) - You have signed informed consent - You are covered by social security or universal medical coverage **You may NOT be eligible if...** - You have already been diagnosed with lung cancer - Lung cancer is strongly suspected based on spread to the lymph nodes or other parts of the body - You are under State Medical Assistance - You are legally restricted from participating (e.g., under guardianship or court order) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBlood samples

Patients will be taken from an additional blood sample (2 tubes of 7.5 mL of blood = 15 mL) during the preoperative check-up on the day of the ultrasound-bronchoscopy in order to compare the sensitivity of the analysis of free circulating DNA present in the supernatant of pulmonary nodules less than 20 mm samples taken under ultrasound-bronchoscopy to that present in the plasma.