CancerECHONCT03062072
Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients
An observational study of Cancer and Colon Cancer, run by National Cancer Center, Korea at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Colon Cancer, Breast Cancer
- What is being tested?
- Chemotherapy
- How many people
- 300 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2015to Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Patients with diabetes mellitus or hyperglycemia, as defined in the protocol
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
National Cancer Center, Korea
Goyang
Su Jeong Go
Eun Kyung Lee
- Recruiting
Seoul National University Boramae Medical Center
Seoul
Bo Kyung Koo, +82-31-920-1743, sjgo@ncc.re.kr
Min Kyong Moon
About this study
Official title: 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.
- Conditions
- Cancer, Colon Cancer, Breast Cancer, Malignant Lymphoma
- Being tested
- Chemotherapy
- Keywords
- normoglycemia, cancer, chemotherapy, Hyperglycemia Drug Induced
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Breast Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called cytotoxic chemotherapeutic agents
Chemotherapy containing glucocorticoid as anti-emetics or anti-cancer agent except for targeted agents
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of type 2 diabetes mellitus
Percentage of patients who progressed to type 2 diabetes
Measured: during chemotherapy (about 1 year)
Secondary outcomes (3)
Change in HbA1c
Measured: during chemotherapy (about 1 year)
Change in glycated albumin
Measured: during chemotherapy (about 1 year)
Recurrence free survival (RFS)
Measured: from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startApr 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Eun Kyung Lee, National Cancer Center, Korea
- Investigators
- Eun Kyung Lee, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062072
- Sponsor's protocol ID
- ECHO
- Other IDs
- NCC2015-0040
- Acronym
- ECHO
- Status last verified
- Apr 2017
- First submitted
- 17 Feb 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33722701
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients (ECHO)
- ClinicalTrials.gov ID
- NCT03062072
- Acronym / sponsor ID
- ECHO / ECHO
- Conditions
- Cancer, Colon Cancer, Breast Cancer, Malignant Lymphoma
- Keywords
- normoglycemia, cancer, chemotherapy, Hyperglycemia Drug Induced
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with diabetes mellitus or hyperglycemia, as defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: cytotoxic chemotherapeutic agentsChemotherapy containing glucocorticoid as anti-emetics or anti-cancer agent except for targeted agents | Drug | – |
Primary outcome
Incidence of type 2 diabetes mellitus
Time frame: during chemotherapy (about 1 year)
Percentage of patients who progressed to type 2 diabetes
3 secondary outcomes
Change in HbA1c
Time frame: during chemotherapy (about 1 year)
Change in glycated albumin
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 33722701Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Kyung Lee principal investigator
National Cancer Center, Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Colon Cancer, run by National Cancer Center, Korea at 2 sites 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Jeong Go (+82-31-920-2364, sjgo@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of type 2 diabetes mellitus (time frame: during chemotherapy (about 1 year)). 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 NCT03062072, which also lists 1 linked publication.
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 7 Apr 2017.