Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059879) titled 'An Observational Study to Evaluate the Clinical Utility of Serial Cancer Gene Panel Testing Using Circulating Tumor DNA in Patients with Metastatic Colorectal Cancer' on Dec. 1.

Study Type: Observational

Primary Sponsor: Institute - Japan Clinical Cancer Research Organization (JACCRO)

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

Objective: Narrative objectives1 - This study will evaluate the clinical utility of performing sequential cancer gene panel testing by analyzing cancer-related genomic alterations-such as base substitutions, insertions/deletions, amplifications, and fusions-using the Guardant360 CDx cancer gene panel (Guardant360) before first-line chemotherapy and after confirmation of disease progression in patients with metastatic colorectal cancer who have not received systemic chemotherapy. The study will determine the proportion of patients with actionable genomic alterations and the proportion in whom such actionable gene alterations change over time. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old =24 weeks [168 days] after the last dose of perioperative chemotherapy is eligible). (5) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. (6) Patients aged 18 years or older at the time of informed consent. (7) Patients expected to survive for at least 3 months. (8) Patients who have received adequate explanation regarding the study and have provided written informed consent. Key exclusion criteria - (1) Patients with active double cancers*, including those occurring in the colon. *Double cancer is defined as synchronous cancers or metachronous cancers with a disease-free interval of <=2 years. Lesions equivalent to carcinoma in situ or intramucosal carcinoma that are curable with local therapy are not considered active double cancers. (2) Patients in whom blood collection is difficult. (3) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult. (4) Any other patients whom the principal investigator or a sub-investigator judges to be unsuitable for safe participation in the study. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 03 Day Date of IRB - 2025 Year 11 Month 11 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2028 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068482

Disclaimer: Curated by HT Syndication.