Tokyo, Sept. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063033) titled 'A study of specimen processing methods to enable genomic testing using malignant pleural effusion from patients with lung cancer' on Sept. 24.

Study Type: Observational

Primary Sponsor: Institute - Kanagawa Cancer Center

Condition: Condition - Malignant pleural effusion from non-squamous non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To evaluate whether CD45-positive cell depletion by magnetic-activated cell sorting (MACS) improves the tumor cell content of FFPE cell blocks derived from malignant pleural effusion in patients with non-squamous non-small cell lung cancer by within-patient comparison with standard processing. The study will also compare DNA/RNA quantity and quality and NGS performance using Oncomine Comprehensive Assay Plus (OCA Plus) between paired specimens to determine whether improved specimen quality translates into improved NGS performance. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with suspected malignant pleural effusion from non-squamous non-small cell lung cancer based on clinical course, imaging, and laboratory findings, or patients already diagnosed with malignant pleural effusion from non-squamous non-small cell lung cancer 2. Patients in whom pleural effusion can be obtained by clinically indicated thoracentesis or chest drainage 3. Both treatment-naive and previously treated patients are eligible, regardless of treatment history 4. Patients aged 18 years or older at the time of informed consent 5. Patients who have received sufficient explanation of the study and provided voluntary written informed consent For patients without a confirmed diagnosis at enrollment, only those subsequently confirmed by pathological evaluation to have malignant pleural effusion derived from non-squamous non-small cell lung cancer will be included in the final study population. Key exclusion criteria - 1. Patients whose pleural effusion is determined not to be malignant by pathological evaluation after collection 2. Patients in whom malignant cells in the pleural effusion cannot be determined to originate from non-squamous non-small cell lung cancer 3. Patients with insufficient residual pleural effusion to prepare cell blocks using both standard processing and MACS processing 4. Patients considered unsuitable for participation by the principal investigator or study investigators Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 06 Month 07 Day Date of IRB - 2026 Year 06 Month 29 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2030 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072131

Disclaimer: Curated by HT Syndication.