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Colorectal CancerSPRINGNCT02700555

Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

An observational study of Colorectal Cancer, run by Kangbuk Samsung Hospital at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Colorectal Cancer
How many people
23 participants
Where
1 siteSouth Korea
Study dates
Feb 2016to Feb 2020
How long will I take part?
60 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who will receive chemotherapy after surgical resection of colorectal cancer

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kangbuk Samsung Hospital

    Seoul, 110-746

Other trials in South Korea

About this study

Official title: Surveillance of Metabolic Parameters in Patients Who Will Receive Chemotherapy After Surgical Resection of Colorectal Cancer: KBSMC Colon Cancer Cohort

A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer

Read the 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

Keywords
colorectal cancer, diabetes, metabolic parameters, Surveillance
Medical subject headings
Colorectal Neoplasms, Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of newly developed diabetes mellitus

    Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy

    Measured: up to 12 months

Secondary outcomes (3)

  1. Pre-operative incidence of diabetes

    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;

    Measured: up to 12 months

  2. Incidence of developed poorly controlled glucose level

    Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy;

    Measured: up to 12 months

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

    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)

    Measured: up to 36-60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

Why it stopped: The patient's study enrollment was too low.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
23 participants (actual)
Target duration
60 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02700555
Sponsor's protocol ID
SPRING
Acronym
SPRING
Status last verified
Dec 2022
First submitted
24 Feb 2016
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21037809

  • 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.

    PubMed 12560431

  • 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.

    PubMed 24105007

  • 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.

    PubMed 25918287

  • 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.

    PubMed 24123849

  • 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.

    PubMed 22594556

  • 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.

    PubMed 24357209

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Kangbuk Samsung Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The patient's study enrollment was too low.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of newly developed diabetes mellitus (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02700555, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.

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