Surveillance of Metabolic Parameters in Patients Who Will Receive Chemotherapy After Surgical Resection of Colorectal Cancer: KBSMC Colon Cancer Cohort
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Incidence of newly developed diabetes mellitus
研究概览
简要总结
A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer
详细描述
Primary objective - Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy
Secondary objective - Pre-operative incidence of diabetes and characteristics of metabolic parameters of patients with colorectal cancer; Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy; 3-year recurrence-free survival according to status of diabetes and metabolic parameters; 5-year recurrence-free survival according to status of diabetes and metabolic parameters
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Who will get surgical resection for colorectal cancer
- •Who has diagnosed with diabetes
- •Who met the criteria for testing of diabetes in asymptomatic adult individuals
- •Criteria for testing for diabetes in asymptomatic adult individuals
- •overweight (BMI>25 kg/m2*) and have additional risk factors (physical inactivity, first-degree relative with diabetes, high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander), women who delivered a baby weighing 0.9 lb or were diagnosed with GDM, hypertension (>140/90 mmHg or on therapy for hypertension), HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L), women with polycystic ovarian syndrome, HbA1C >5.7%, IGT, or IFG on previous testing, other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans), history of CVD)
排除标准
- •Previously exposed to surgery or chemotherapy for colorectal cancer
- •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
- •Presence of CNS metastasis
- •Not able or willing to give informed consent
- •Any patients judged by the investigator to be unfit to participate in the study
结局指标
主要结局
Incidence of newly developed diabetes mellitus
时间窗: up to 12 months
Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy
次要结局
- 3-year recurrence-free survival & 5-year recurrence-free survival(up to 36-60 months)
- Pre-operative incidence of diabetes(up to 12 months)
- Incidence of developed poorly controlled glucose level(up to 12 months)
研究者
Dong-Hoe Koo
Assistant Professor
Kangbuk Samsung Hospital