Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients
ECHO
2 other identifiers
observational
300
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 7, 2017
April 1, 2017
2.7 years
February 17, 2017
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of type 2 diabetes mellitus
Percentage of patients who progressed to type 2 diabetes
during chemotherapy (about 1 year)
Secondary Outcomes (3)
Change in HbA1c
during chemotherapy (about 1 year)
Change in glycated albumin
during chemotherapy (about 1 year)
Recurrence free survival (RFS)
from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months
Interventions
Chemotherapy containing glucocorticoid as anti-emetics or anti-cancer agent except for targeted agents
Eligibility Criteria
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)
You may qualify if:
- 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
You may not qualify if:
- Patients with diabetes mellitus or hyperglycemia, as defined in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Center, Korealead
- SMG-SNU Boramae Medical Centercollaborator
Study Sites (2)
National Cancer Center, Korea
Goyang, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Related Publications (1)
Lee EK, Koo B, Hwangbo Y, Lee YJ, Baek JY, Cha YJ, Kim SY, Sim SH, Lee KS, Park IH, Lee H, Joo J, Go S, Heo SC, Moon MK. Incidence and disease course of new-onset diabetes mellitus in breast and colorectal cancer patients undergoing chemotherapy: A prospective multicenter cohort study. Diabetes Res Clin Pract. 2021 Apr;174:108751. doi: 10.1016/j.diabres.2021.108751. Epub 2021 Mar 17.
PMID: 33722701DERIVED
Biospecimen
serum, plasma, buffy coat
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eun Kyung Lee
National Cancer Center, Korea
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 17, 2017
First Posted
February 23, 2017
Study Start
April 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2022
Last Updated
April 7, 2017
Record last verified: 2017-04