Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Surveillance of Metabolic Parameters in Patients Who Will Receive Chemotherapy After Surgical Resection of Colorectal Cancer: KBSMC Colon Cancer Cohort

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of newly developed diabetes mellitus | Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative incidence of diabetes | Pre-operative incidence of diabetes (> 6.5% of HbA1c) and abnormal metabolic parameters (> 23 kg/m2 of BMI or dyslipidemia) of patients with colorectal cancer; | up to 12 months | 
| Incidence of developed poorly controlled glucose level | Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy; | up to 12 months | 
| 3-year recurrence-free survival & 5-year recurrence-free survival | 3-year and 5-year recurrence-free survival according to status of diabetes (> 6.5% of HbA1c) and abnormal metabolic parameters (> 23 kg/m2 of BMI or dyslipidemia) | up to 36-60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, diabetes, metabolic parameters, Surveillance