Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02700555

Acronym

SPRING

Enrollment

Registered

2016-03-07

Start date

2016-02-29

Completion date

2020-02-29

Last updated

2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal cancer, diabetes, metabolic parameters, Surveillance

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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;
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)

Countries

South Korea

Outcome results