Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients (ECHO)

April 5, 2017 updated by: Eun Kyung Lee, National Cancer Center, Korea

Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients (ECHO)

To assess chemotherapy related hyperglycemia in non-diabetic patients, the investigators will assess the incidence of hyperglycemia and analyze co-medications and risk factors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Goyang, Korea, Republic of
        • Recruiting
        • National Cancer Center, Korea
        • Principal Investigator:
          • Eun Kyung Lee
        • Contact:
          • Su Jeong Go
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Min Kyong Moon
        • Sub-Investigator:
          • Bo Kyung Koo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with advanced cancers (colorectal, breast) who treated with curative intents, and ones with malignant lymphoma who are expected to achieve complete remission with chemotherapy (mainly, CHOP regimen)

Description

Inclusion Criteria:

  • Patients with cancers (colorectal, breast) who treated with curative intents and ones with malignant lymphoma who are expected to achieve complete remission with chemotherapy (mainly, CHOP regimen)
  • Patients without history of diabetes mellitus
  • Normal glucose tolerance, as defined in the protocol

Exclusion Criteria:

  • Patients with diabetes mellitus or hyperglycemia, as defined in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of type 2 diabetes mellitus
Time Frame: during chemotherapy (about 1 year)
Percentage of patients who progressed to type 2 diabetes
during chemotherapy (about 1 year)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: during chemotherapy (about 1 year)
during chemotherapy (about 1 year)
Change in glycated albumin
Time Frame: during chemotherapy (about 1 year)
during chemotherapy (about 1 year)
Recurrence free survival (RFS)
Time Frame: from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months
from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Eun Kyung Lee, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECHO
  • NCC2015-0040 (Other Identifier: NCC Korea)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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