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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030495
Receipt No. 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 2018/12/24

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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 (n=130) were utilized from Tohoku Medical Megabank as a collaboration.
Key exclusion criteria The patient whom the researcher consider to be inappropriate for the study.
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kawakami
Organization Nagasaki University Hospital
Division name Department of Immunology and Rheumatology
Zip code
Address 1-7-1 Sakamoto Nagasaki, Japan
TEL 095-819-7260
Email atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Abiru
Organization Nagasaki University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 1-7-1 Sakamoto Nagasaki, Japan
TEL 095-819-7260
Homepage URL
Email abirun@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034813

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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