Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060568) titled 'Research on the Development of a System for Measuring the Blood Concentration of Bevacizumab Using a Flow Cytometer' on April 1.

Study Type: Observational

Primary Sponsor: Institute - Mie University

Condition: Condition - Colorectal Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to develop a method for measuring serum concentrations of bevacizumab applicable to routine clinical practice using a novel technique based on flow cytometry employing antigen-capture beads and detection antibodies. Basic objectives2 - PK,PD

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - To participate in this study, all of the following criteria must be met. 1) Patients with unresectable advanced or recurrent colorectal cancer undergoing repeated administration of bevacizumab at 5-10 mg/kg (body weight) per dose, administered at least three times, in the Department of Gastrointestinal Surgery at our hospital between the date of approval and March 31, 2028. 2) Patients whose background information can be verified in medical records. 3) Patients whose informed consent to participate in the study can be confirmed based on their own volition. Key exclusion criteria - Participants will be excluded from this study if they meet any of the following criteria: 1) Individuals for whom written consent to participate in the study could not be obtained 2) Individuals for whom a blood draw order was not placed within one month after consent was obtained 3) Patients under 18 years of age 4) Patients of foreign nationality Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 03 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069278

Disclaimer: Curated by HT Syndication.