Surveillance of Metabolic Parameters in Patients With Colorectal Cancer (SPRING)

Kangbuk Samsung Hospital

Status: Terminated

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02700555

SPRING (Other Identifier)

Details and patient eligibility

About

A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer

Full 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

Enrollment: 23 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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