Surveillance of Metabolic Parameters in Patients Who Will Receive Chemotherapy After Surgical Resection of Colorectal Cancer: KBSMC Colon Cancer Cohort
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Kangbuk Samsung Hospital
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Incidence of newly developed diabetes mellitus
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer
Detailed Description
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
Investigators
Dong-Hoe Koo
Assistant Professor
Kangbuk Samsung Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence of newly developed diabetes mellitus
Time Frame: up to 12 months
Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy
Secondary Outcomes
- 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)