Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062331) titled 'Prospective multicenter observational study evaluating the diagnostic utility of Rapid On-Site Evaluation of touch-imprint cytology during bronchoscopic biopsy with small forceps for peripheral pulmonary lesions' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - NHO Okayama Medical Center

Condition: Condition - lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This observational study aims to determine whether rapid on-site evaluation using touch imprint cytology (ROSE-TIC) of small-forceps biopsy specimens can serve as a diagnostic adjunct for chest abnormalities suspicious for lung cancer. Specifically, in rEBUS-guided bronchoscopy for peripheral pulmonary lesions, we will evaluate the incremental diagnostic yield achieved by adding or modifying sampling procedures in patients with negative ROSE-TIC results and assess its clinical utility. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with pulmonary lesions suspicious for malignancy on chest radiography and/or chest computed tomography performed within 1 month before bronchoscopy, who are scheduled to undergo bronchoscopic forceps biopsy to determine the treatment strategy. Patients scheduled to initially undergo either thin bronchoscopy with the EBUS-GS technique or small-forceps biopsy using an ultrathin bronchoscope. Patients aged 18 years or older. Patients from whom written informed consent for participation in this study has been obtained. Key exclusion criteria - Patients meeting any of the following criteria will be excluded from this clinical study:

Patients in whom a diagnosis other than lung cancer is strongly suspected. Patients with lesions located within the inner one-third of the distance from the pulmonary hilum. Patients scheduled to initially undergo EBUS-TBNA or direct-vision biopsy. Patients with lesions adjacent to major blood vessels. Pregnant women or women who may be pregnant. Patients receiving anticoagulant or antiplatelet therapy that cannot be discontinued for the procedure. Patients with a marked bleeding tendency. Patients considered unsuitable for bronchoscopy because of thrombocytopenia (platelet count <50,000/uL) or coagulation abnormalities (prothrombin time or activated partial thromboplastin time) identified on blood testing performed within 1 month before the procedure. Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 08 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071068

Disclaimer: Curated by HT Syndication.