Lung Cancer Clinical Trial
— KOBEOfficial title:
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules (Cancer Or Benign Endoscopy) (KOBE)
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
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Toulouse University Hospital | Toulouse | Occitanie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopy | |
Secondary | 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. |
1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopy |
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