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NCT03062072 Clinical Trial

Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients

Breast Cancer Clinical Trial

— ECHO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03062072
Other study ID # ECHO
Secondary ID NCC2015-0040
Status Recruiting
Phase N/A
First received February 17, 2017
Last updated April 5, 2017
Start date April 2015
Est. completion date December 2022

Study information
Verified date April 2017
Source National Cancer Center, Korea
Contact Su Jeong Go
Phone +82-31-920-2364
Email sjgo@ncc.re.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2022
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Chemotherapy
Chemotherapy containing glucocorticoid as anti-emetics or anti-cancer agent except for targeted agents

Locations
Country Name City State
Korea, Republic of National Cancer Center, Korea Goyang
Korea, Republic of Seoul National University Boramae Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
National Cancer Center, Korea SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of type 2 diabetes mellitus Percentage of patients who progressed to type 2 diabetes during chemotherapy (about 1 year)
Secondary Change in HbA1c during chemotherapy (about 1 year)
Secondary Change in glycated albumin during chemotherapy (about 1 year)
Secondary Recurrence free survival (RFS) from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months
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