UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030495 |
|---|---|
| Receipt number | R000034813 |
| Scientific Title | An exploratory study to determine the genetic polymorphisms or mutations associated with type 1 diabetes and interstitial lung disease induced by immune checkpoint inhibitor; nivolumab |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2021/07/02 17:00:22 |
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Basic information
Public title
An exploratory study to determine the genetic polymorphisms or mutations associated with type 1 diabetes and interstitial lung disease induced by immune checkpoint inhibitor; nivolumab
Acronym
An exploratory study to determine the irAE-related genes induced by immune checkpoint inhibitor; nivolumab
Scientific Title
An exploratory study to determine the genetic polymorphisms or mutations associated with type 1 diabetes and interstitial lung disease induced by immune checkpoint inhibitor; nivolumab
Scientific Title:Acronym
An exploratory study to determine the irAE-related genes induced by immune checkpoint inhibitor; nivolumab
Region
| Japan |
Condition
Condition
type 1 diabetes
interstitial lung disease
Classification by specialty
| Pneumology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of study to identify the causal variants or mutations associated with immune-related adverse events (type 1 diabetes and interstitial lung disease) of anti-PD-1 antibody; nivolumab by whole genome analysis in multi-center cohort study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Allele frequency of causal variants or mutations associated with immune-related adverse events of nivolumab
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
The cohort includes the patients treated with nivolumab who develops type 1 diabetes (n=15) and interstitial lung disease(n=50) as case group and the patients without immune-related adverse events (n=65) as control group. Whole genome data in healthy subjects were utilized from Tohoku Medical Megabank or NBDC as a collaboration.
Key exclusion criteria
The patient whom the researcher consider to be inappropriate for the study.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology
Zip code
852-8501
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7260
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Abiru |
Organization
Nagasaki University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7260
Homepage URL
abirun@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Investigators Supported Research Grants from ONO PHARMACEUTICAL CO. LTD. and Bristol-Myers Squibb
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital
Tochigi cancer center
Kyusyu University
Kurume University
University of Occupational and Environmental Health
Fukuoka University
Oita University
Kumamoto University
Kagoshima University
University of the Ryukyu
University of Miyazaki
Saga University
Tokai University School of Medicine
Japanese Red Cross Nagasaki Genbaku Hospital
National Hospital Nagasaki Medical Center
JCHO Isahaya General Hospital
Nagasaki Prefecture Shimabara Hospital
Sasebo City General Hospital
Kitakyusyu Munincipal Medical Center
NHO Fukuoka Higashi Medical Center
NHO Ureshino Medical Center
JCHO Kyusyu Hospital
Kagoshima City Hospital
Saitama Medical University International Medicak Center
Hokkaido University
Kanazawa University
Kyoto Prefectural University of Medicine
Okayama University
Chiba University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto Nagasaki-shi, Nagasaki-ken
Tel
095-819-7905
gaibushikin@ml.nagasaki-u.ac.jp
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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 21 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Collecting information
1. for case and control
sex, age, height, weight, primary disease to nivolumab, the date of start of nivolumab, number of nivolumab injection
2-1. for type 1 diabetes case
Hyperglycemic symptom, the date of unconsciousness or diagnosis of type 1 diabetes
Exam on diagnosis;
Blood and biochemistry; WBC, RBC, Hb, Hct, Pelt, Plasma glucose, HbA1c, Urine or blood Ketone body, blood gas, pancreatic enzyme(Amylase, elastase1, lipase), anti-GAD antibody, serum and urine C-peptide,
2-2. for interstitial lung disease case
initial symptom (short of breath, dyspnea, cough), the date of audible of rale or diagnosis of interstitial lung disease
Treatment for interstitial lung disease
Exam on diagnosis;
Image;chest X-ray, HRCT
Blood and biochemistry; WBC, RBC, Hb, Hct, Plt, CRP, AST, ALT, g-GTP, KL-6,SP-A, SP-D, blood gas
Exam for differential diagnosis;
b-D-glucan, cytomegalo virus antigen, sputum examination (Bacterial smear or culture)
3.genome data;
Genomic DNA from obtained 10mL of blood sample is collected. The genome DNA is analyzed by whole genome analysis to serach for the causal variants or mutations associated with immune-related adverse events (type 1 diabetes and interstitial lung disease) of anti-PD-1 antibody; nivolumab.
4. Serum sample data
Serum sample is collected and the level of anti-GAD, serum-C-peptide, KL-6 and SP-D are measured to support the diagnosis of disease or non-disease.
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034813
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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