Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

NCT02700555 | Terminated

• 1 other identifier: SPRING
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

colorectal cancer; diabetes; metabolic parameters; Surveillance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pre-operative incidence of diabetes

  up to 12 months

• Incidence of developed poorly controlled glucose level

  up to 12 months

• 3-year recurrence-free survival & 5-year recurrence-free survival

  up to 36-60 months

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will receive chemotherapy after surgical resection of colorectal cancer

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Related Publications (7)

• 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.

  PMID: 21037809 BACKGROUND

• 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.

  PMID: 12560431 BACKGROUND

• 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.

  PMID: 24105007 BACKGROUND

• 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.

  PMID: 25918287 BACKGROUND

• 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.

  PMID: 24123849 BACKGROUND

• 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.

  PMID: 22594556 BACKGROUND

• 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.

  PMID: 24357209 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dong-Hoe Koo, MD,PhD

  Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 7, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

KR (1)