Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062673) titled 'Performance study of the POPLAR system, a diagnostic system for molecular subtype classification of endometrial cancer' on Aug. 26.

Study Type: Observational

Primary Sponsor: Institute - Hokkaido University

Condition: Condition - Endometrial cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The objective of this study is to verify that the analytical performance of the POPLAR system, a diagnostic gene panel testing system for molecular subtype classification of endometrial cancer, is equivalent to that of existing testing methods used as reference methods. The results of this study will be used for regulatory application of the POPLAR system as Software as a Medical Device (SaMD). Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Patients aged 18 years or older at the time of consent 2. Patients pathologically diagnosed with endometrial cancer 3. Patients from whom a sufficient amount of tumor tissue required for the tests in this study can be provided 4. Patients who have provided written informed consent to participate in this study of their own free will, or patients for whom consent has been obtained for the use of samples and information in future medical research under a comprehensive consent system or equivalent framework at the participating institution Key exclusion criteria - Patients judged by the principal investigator to be inappropriate for participation in this study Target Size - 550

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 28 Day Date of IRB - 2025 Year 12 Month 03 Day Anticipated trial start date - 2025 Year 12 Month 24 Day Last follow-up date - 2027 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071387

Disclaimer: Curated by HT Syndication.