Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Blood samples
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov