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Trial record 87 of 1005 for:    colon cancer AND resection

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

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
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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: Surveillance of Metabolic Parameters in Patients Who Will Receive Chemotherapy After Surgical Resection of Colorectal Cancer: KBSMC Colon Cancer Cohort
Study Start Date : February 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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;

  2. 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. 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)


Biospecimen Retention:   Samples Without DNA
Tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who will receive chemotherapy after surgical resection of colorectal cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700555


Contacts
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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

Locations
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Korea, Republic of
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 110-746
Contact: Dong-Hoe Koo, MD,PhD    +82-2-2001-8330    d.h.koo@samsung.com   
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
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Principal Investigator: Dong-Hoe Koo, MD,PhD Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Additional Information:

Publications:
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Responsible Party: Dong-Hoe Koo, Assistant Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02700555     History of Changes
Other Study ID Numbers: CA02
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dong-Hoe Koo, Kangbuk Samsung Hospital:
colorectal cancer
diabetes
metabolic parameters
Surveillance
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases