lung cancer
Conditions
Interventions
Bronchoscopy is performed for diagnostic purposes in patients suspected of malignant lung tumor. First, a radial EBUS is inserted into the access bronchus estimated by prior bronchus sketching or navi
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients suspected of having lung cancer (non-small cell lung cancer) and who require a cytological or tissue diagnosis. 2. Patients aged 20 years or older. 3. Patients who have given written informed consent to participate. 4. Patients expected to progress to clinical stage 3 (locally advanced stage) or advanced (stage 4).
Exclusion criteria
Exclusion criteria: Exclusion criteria (primary registration) 1) Patients who the principal investigator (physician) or co-investigator (physician) judges to be inappropriate for participation in this study. Exclusion criteria (secondary registration) 1) Patients for whom saline injection is expected to affect subsequent direct procedures 2) Tumors clearly exposed under direct vision (epithelial changes due to lymphangiectasia carcinomatosis are acceptable) 3) Patients for whom identification of communicating bronchi or wedge of the scope is extremely difficult (the degree of wedge during bronchial lavage in daily practice is acceptable) 4) Tumor signals are not observed or are not within the tumor when rEBUS is inserted before saline injection 5) No malignant cells are confirmed by direct method (not a malignant lesion) 6) No malignant cells are confirmed by lavage fluid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of gene mutations in cytology-positive washing fluids (positive and negative agreement rates with the conventional method) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Correlation between gene mutation allele ratios using the conventional method and the washing method 2. Comparison of test success rates and nucleic acid yields (DNA/RNA) using the conventional method and the washing method 3. Gene mutation detection rate in cytology negative washing fluid 4. Gene mutation detection rate by disease stage/tumor size 5. Tumor cell count and tumor cell content in paired samples 6. Correlation between allele frequency and therapeutic effect of molecular targeted drugs 7. Correlation between positive/negative agreement rate and allele frequency of plasma compact panel test with conventional method 8. Positive/negative agreement rate of plasma compact panel test with Cobas test | — |
Countries
Japan
Contacts
Public ContactKei Morikawa
St. Marianna University School of Medicine Division of Respiratory Diseases, Department of Internal Medicine
Outcome results
None listed