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

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ClinicalTrials.gov Identifier: NCT02700555
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-Hoe Koo, Kangbuk Samsung Hospital

Tracking Information
First Submitted Date February 24, 2016
First Posted Date March 7, 2016
Last Update Posted Date March 15, 2018
Study Start Date February 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2016)
Incidence of newly developed diabetes mellitus [ Time Frame: up to 12 months ]
Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02700555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2016)
  • Pre-operative incidence of diabetes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surveillance of Metabolic Parameters in Patients With Colorectal Cancer
Official Title Surveillance of Metabolic Parameters in Patients Who Will Receive Chemotherapy After Surgical Resection of Colorectal Cancer: KBSMC Colon Cancer Cohort
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

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 60 Months
Biospecimen Retention:   Samples Without DNA
Description:
Tumor tissue
Sampling Method Probability Sample
Study Population Patients who will receive chemotherapy after surgical resection of colorectal cancer
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 1, 2016)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dong-Hoe Koo, MD,PhD +82-2001-8330 d.h.koo@samsung.com
Contact: Cheol-Young Park, MD,PhD +82-2001-8330 cyber.park@samsung.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02700555
Other Study ID Numbers CA02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dong-Hoe Koo, Kangbuk Samsung Hospital
Study Sponsor Kangbuk Samsung Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Dong-Hoe Koo, MD,PhD Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
PRS Account Kangbuk Samsung Hospital
Verification Date March 2018