Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062925) titled 'The observational study to evaluate the diagnostic value of Next generation sequencer (NGS) and PCR method for detecting driver oncogene and clinical course' on Sept. 14.

Study Type: Observational

Primary Sponsor: Institute - Saiseikai Matsusaka Municipal Hospital

Condition: Condition - Non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The objective of this prospective observational study is to evaluate the concordance of driver oncogene alterations detected by next-generation sequencing (NGS), primarily Oncomine, and PCR-based testing, primarily AmoyDx, in patients with non-small cell lung cancer, and to evaluate treatment outcomes and clinical courses according to the results of these molecular tests. Factors potentially affecting test results and subgroup analyses according to patient characteristics and genomic alterations will also be explored. As an ancillary exploratory analysis, prospectively collected plasma samples analyzed using the Oncomine Precision Assay (OPA) will be used to evaluate the frequency of TP53 mutations, TP53 variant subtypes, and their associations with prior treatment exposure and survival outcomes. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with a pathologically confirmed diagnosis of non-small cell lung cancer. 2. Patients who provide consent to undergo genomic testing, or patients who have previously undergone genomic testing using NGS or AmoyDx and provide consent for participation in the study. Key exclusion criteria - 1. Patients from whom informed consent for study participation cannot be obtained. 2. Patients considered inappropriate for participation by the investigators. Target Size - 500

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2022 Year 03 Month 04 Day Date of IRB - 2022 Year 04 Month 01 Day Anticipated trial start date - 2022 Year 04 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072042

Disclaimer: Curated by HT Syndication.