Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062248) titled 'Comprehensive cancer genomic profiling before completion of standard therapy' on July 15.

Study Type: Interventional

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

Primary Sponsor: Institute - Tokushima University

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

Objective: Narrative objectives1 - This study aims to evaluate the clinical utility of performing comprehensive cancer genomic profiling (CGP) before the completion, or anticipated completion, of standard treatment in patients with advanced or recurrent solid tumors who are candidates for systemic therapy but are not eligible to undergo CGP testing under the national health insurance system before completing standard treatment because of current reimbursement requirements. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - CGP testing using tumor tissue and or peripheral blood samples is performed in patients with solid tumors before completion of standard therapy including those expected to complete standard therapy, and the results are reviewed by an expert panel for consideration of treatment strategy.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Pathologically proven solid tumor 2) Advanced or recurrent stage eligible for systemic chemotherapy 3) The CGP test covered by insurance has not yet been performed 4) The attending physician must determine that the current CGP test is not covered by insurance at the time of study enrollment 5) Samples can be submitted suitable for genetic analysis (at least one of items 1 or 2). 1. Post-treatment residual tumor tissue sample 2. Peripheral blood samples collected specifically for this study 6) The patient consented to registering their information with the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) and using their data 7) Written consent for partcipation in this study must be obtained from the patient (for patients under 18 years of age, consent from a legal representative is required inaddition to the patient's consent). However, even if the patient understands the information provided and wishes to give consent, but is unable to sign due to neurological symptoms or other reasons, and the patient so desires, a proxy may sign on the patient's behalf to confirm consent. Key exclusion criteria - 1) Patients who have already participated in this study and have previously undergone CGP testing under the framework of Advanced Medical Care A. Target Size - 500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 15 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2031 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071230

Disclaimer: Curated by HT Syndication.