Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Gene expression and lymphocyte infiltration of the tumor
研究概览
简要总结
The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery.
The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside.
The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing curative intended surgery for colon or rectum cancer
- •UICC stage I-III
排除标准
- •Neoadjuvant oncological treatment
- •Acute / subacute surgery
- •Palliative surgery
- •Other pathology than adenocarcinoma
研究组 & 干预措施
Iron(III)isomaltoside 1000
Anemic patients receiving treatment with iron(III)isomaltoside
干预措施: Iron(III)isomaltoside (Drug)
结局指标
主要结局
Gene expression and lymphocyte infiltration of the tumor
时间窗: 1 day after surgery
770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor
Complications
时间窗: 30 days after surgery
Postoperative complications after surgery measured by the Clavien-Dindo classification
次要结局
- Length of stay(up to 100 days)
- Readmission(Within 30 days after surgery)
- Time to chemotherapy(up to 100 days)
- Perioperative blood transfusions(from outpatient assesment to 30 days after surgery)
- Mortality(30 days, 90 days and one year)