UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026702 |
|---|---|
| Receipt number | 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 11:02:54 |
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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
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
mayu-w@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030653
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