Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Recruiting · NCT05306912 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
1 location listed.
- Toulouse University Hospital - Toulouse, Occitanie, France