A Prospective multicenter study for evaluation of the Accuracy and clinical usefulness of the high-sensitivity NExt-generation sequencing panel using bronchial washing fluid from Lung cancer

UMIN ID: UMIN000056642

Registered date:06/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lung cancer
• Date of first enrollment: 2025/01/06
• Target sample size: 93
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 navigation software, and once the lesions is confirmed, the radial EBUS is removed. The scope is then wedged and washed with normal saline, and the washing fluids are collected in a container.

Outcome(s)

• Primary Outcome: Detection rate of gene mutations in cytology-positive washing fluids (positive and negative agreement rates with the conventional method)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: St. Marianna University School of Medicine
• Source(s) of Monetary Support: DNA Chip Research Inc.,Japan Society for Respiratory Endoscopy
• Secondary ID(s): Clinical trial number #6621