Blood 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* rEBUS bronchoscopy planned for one, two or three ≤ 20 mm nodule
* World Health Organization (WHO) Performance status 0-3
* Informed signed consent
* Patient affiliated or beneficiary of a social security scheme (Social Security or Universal Medical Coverage).
Exclusion Criteria:
* Lung cancer diagnosed before the date of the procedure
* Lung cancer strongly suspected due to mediastinal or extra thoracic lesions
* Patient under State Medical Assistance
* Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice
Primary outcome measure(s)
Sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule will be evaluated. — 1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopy Promoter methylation rates of the 9 targeted genes in the free circulating DNA of the endoscopic samples supernatant is obtained by quantitative Polymerase Chain Reaction (PCR) of bisulfite-treated DNA fragments from the cytological samples supernatant after DNA concentration and separation by size at the Centre of Cancer Research of Toulouse (CRCT).
These analyses will be performed blinded to the clinical data and the histopathology result of the lung nodule.
Trial sites (1)
Facility
City
Region
Status
Toulouse University Hospital
Toulouse
Occitanie
Recruiting
More University Hospital, Toulouse trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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