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

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

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

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-746
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who will receive chemotherapy after surgical resection of colorectal cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Investigators: Principal Investigator: Dong-Hoe Koo, MD,PhD, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Publications and helpful links

General Publications

• American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.
• Haggar FA, Boushey RP. Colorectal cancer epidemiology: incidence, mortality, survival, and risk factors. Clin Colon Rectal Surg. 2009 Nov;22(4):191-7. doi: 10.1055/s-0029-1242458.
• Meyerhardt JA, Catalano PJ, Haller DG, Mayer RJ, Macdonald JS, Benson AB 3rd, Fuchs CS. Impact of diabetes mellitus on outcomes in patients with colon cancer. J Clin Oncol. 2003 Feb 1;21(3):433-40. doi: 10.1200/JCO.2003.07.125.
• Mills KT, Bellows CF, Hoffman AE, Kelly TN, Gagliardi G. Diabetes mellitus and colorectal cancer prognosis: a meta-analysis. Dis Colon Rectum. 2013 Nov;56(11):1304-19. doi: 10.1097/DCR.0b013e3182a479f9.
• Dienstmann R, Salazar R, Tabernero J. Personalizing colon cancer adjuvant therapy: selecting optimal treatments for individual patients. J Clin Oncol. 2015 Jun 1;33(16):1787-96. doi: 10.1200/JCO.2014.60.0213. Epub 2015 Apr 27.
• Hwang JL, Weiss RE. Steroid-induced diabetes: a clinical and molecular approach to understanding and treatment. Diabetes Metab Res Rev. 2014 Feb;30(2):96-102. doi: 10.1002/dmrr.2486.
• Feng JP, Yuan XL, Li M, Fang J, Xie T, Zhou Y, Zhu YM, Luo M, Lin M, Ye DW. Secondary diabetes associated with 5-fluorouracil-based chemotherapy regimens in non-diabetic patients with colorectal cancer: results from a single-centre cohort study. Colorectal Dis. 2013 Jan;15(1):27-33. doi: 10.1111/j.1463-1318.2012.03097.x.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: diabetes; colorectal cancer; Surveillance; metabolic parameters
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SPRING (Other Identifier: University Hospital A Coruña)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided