Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

Terminated

• Conditions: Colorectal Cancer

• Registration Number: NCT02700555
• Lead Sponsor: Kangbuk Samsung Hospital

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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of newly developed diabetes mellitus	up to 12 months	Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy

Secondary Outcome Measures

Name	Time	Method
3-year recurrence-free survival & 5-year recurrence-free survival	up to 36-60 months	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)
Pre-operative incidence of diabetes	up to 12 months	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;
Incidence of developed poorly controlled glucose level	up to 12 months	Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy;

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of