SPRING: Surveillance of Metabolic Parameters in Patients With Colorectal Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 110-746 |
Sponsors and Collaborators
- Kangbuk Samsung Hospital
Investigators
- Principal Investigator: Dong-Hoe Koo, MD,PhD, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Study Documents (Full-Text)
None provided.More Information
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.
- 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. Review.
- 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.
- 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.
- 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. Review.
- 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.
- 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. Review.
- CA02