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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Blood samples
Biological/VaccinePatients 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: blood samplingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule will be evaluated.
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.
Time frame
1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopySecondary outcomes
1
Comparison of supernatant to pathology and plasma cfDNA methylation analysis. Specificity, negative predictive value (NPV), positive predictive value (PPV) of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule
Methylation profiles of free circulating DNA from plasma obtained after centrifugation of blood samples will be obtained by the same method as described for analysis of cytopunction's supernatant methylation profile. These analyses will be performed blinded to the clinical data and the histopathology result of the lung nodule.
Time frame
1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopySponsors and contacts
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Source ClinicalTrials.gov