Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

NCT ID: NCT02700555

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-02-29

Brief Summary

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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

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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

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Hoe Koo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Hoe Koo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 21037809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12560431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24105007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25918287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24123849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22594556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24357209 (View on PubMed)

Other Identifiers

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SPRING

Identifier Type: -

Identifier Source: org_study_id

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