Clinical Trial: A prospective multicenter observational study investigating the association between the improvement rate of preoperative anemia and treatment outcomes in colorectal cancer (Japan)

Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061318) titled 'A prospective multicenter observational study investigating the association between the improvement rate of preoperative anemia and treatment outcomes in colorectal cancer' on April 20.

Study Type: Observational

Primary Sponsor: Institute - Yokohama City University

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

Objective: Narrative objectives1 - This study aims to clarify, in colorectal cancer patients scheduled for primary tumor resection who present with anemia at the initial visit, the real-world status of preoperative anemia management in routine clinical practice, as well as the association between changes in hemoglobin levels after treatment and perioperative outcomes. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with histologically confirmed colorectal cancer Patients scheduled for primary tumor resection Patients whose hemoglobin level at the initial visit meets the following criteria: Male: < 13.0 g/dL Female: < 12.0 g/dL Key exclusion criteria - Patients undergoing emergency surgery with primary tumor resection Patients with severe anemia requiring blood transfusion at the initial visit Patients with contraindications to iron therapy (e.g., hepatic or renal dysfunction, myelodysplastic syndromes [MDS], hemochromatosis, thalassemia, hemolytic anemia) Patients who have already received preoperative anemia treatment (blood transfusion within 1 month or erythropoietin use within 3 months) Patients deemed unsuitable for participation in this study by the principal investigator Target Size - 200

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 16 Day Date of IRB - 2026 Year 03 Month 23 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070156

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