Tokyo, June 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061993) titled 'A Prospective Study Evaluating the Clinical Utility of Comprehensive Genomic Testing Before Completion of Standard Treatment in Patients With Advanced or Recurrent Cancer' on June 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Okayama University

Condition: Condition - Patients with advanced or recurrent solid tumors who are candidates for systemic therapy and are not eligible to undergo comprehensive genomic profiling (CGP) testing under the national insurance system before completion (or anticipated completion) of standard treatment. Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To evaluate the clinical utility of performing comprehensive genomic profiling (CGP) before completion, or anticipated completion, of standard treatment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Japan-approved comprehensive genomic profiling (CGP) tests

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with advanced or recurrent solid tumors who are candidates for systemic therapy. 2. No prior comprehensive genomic profiling (CGP) testing reimbursed under the national health insurance system. 3. The treating physician determines that the patient is not currently eligible for insurance-covered CGP testing under the prevailing reimbursement criteria at the time of study enrollment. 4. Availability of specimens suitable for genomic analysis, including archived tumor tissue and/or newly collected peripheral blood samples. 5. Willingness to have clinical and genomic data registered in the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) database and utilized for research purposes. 6. Provision of written informed consent by the patient prior to participation in the study. Key exclusion criteria - Patients who have previously enrolled in this study and undergone CGP testing under the framework of Advanced Medical Care A. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 28 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2032 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070941

Disclaimer: Curated by HT Syndication.