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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026702
Receipt No. R000030653
Scientific Title Investigation of risk factors for the onset of glucose intolerance and thyroid disease in patients with the immune checkpoint inhibitors
Date of disclosure of the study information 2017/04/25
Last modified on 2020/03/30

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Basic information
Public title Investigation of risk factors for the onset of glucose intolerance and thyroid disease in patients with the immune checkpoint inhibitors
Acronym Investigation of risk factors for the onset of glucose intolerance and thyroid disease in patients with the immune checkpoint inhibitors
Scientific Title Investigation of risk factors for the onset of glucose intolerance and thyroid disease in patients with the immune checkpoint inhibitors
Scientific Title:Acronym Investigation of risk factors for the onset of glucose intolerance and thyroid disease in patients with the immune checkpoint inhibitors
Region
Japan

Condition
Condition melanoma, lung cancer
Classification by specialty
Pneumology Endocrinology and Metabolism Dermatology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The immune checkpoint inhibitors have been shown to be effective in treating several types of cancer, including melanoma, non-small cell lung cancer, and renal-cell cancer. They can cause serious side effects, including type 1 diabetes mellitus, impaired glucose tolerance, and thyroid dysfunction. Previous studies reported that the type 1 diabetes mellitus develop within 6 months after treatment with the immune checkpoint inhibitors, and sometime occur with autoimmune thyroid disease. However, risk factors for the onset of glucose intolerance and thyroid disease in patients with the immune checkpoint inhibitors remains unclear. In the present study, we analyze the genetic and clinical characteristics of the patients with the immune checkpoint inhibitors to investigate the risk factors for the onset of glucose intolerance and thyroid disease.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The onset of glucose intolerance and thyroid function after the immune checkpoint inhibitors
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1, The patients who received treatment of the immune checkpoint inhibitors from July 1th,2014 to March 31,2020 in Okayama university hospital.
2, The patients who were over 20 years old and could agree to be study participants voluntary.
3, Not establish the criteria of gender.
Key exclusion criteria The patients whose ADL weakened remarkably.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Wada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7235
Email junwada@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Jun / Mayu
Middle name
Last name Eguchi/ Watanabe
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7235
Homepage URL
Email mayu-w@okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel 086-235-7235
Email none

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 90
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 02 Month 14 Day
Date of IRB
2017 Year 03 Month 31 Day
Anticipated trial start date
2017 Year 04 Month 25 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information We perform blood exam before and one month, 6months and 1 year after first treatment with the immune checkpoint inhibitors, or every 6 months after obtaining informed consent.
We collect clinical data, including subject identification code, date of birth, age, sex, height, body weight, complications, past medical history, duration of diabetes, treatment for diabetes, history of alcohol intake, history of smoking, family history, primary cancer (size/region/invasion into pancreas/operative procedure/TNM classification/radiation therapy/ chemotherapy), and undergo blood test, including HbA1c, fasting C peptide, fasting plasma glucose, anti-GAD antibody, IA-2 antibody, fasting insulin, HLA, FT3, FT4, TSH, anti-TPO antibody, anti-thyroglobulin antibody, anti-nuclear antibody.

Management information
Registered date
2017 Year 03 Month 25 Day
Last modified on
2020 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030653

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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