UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000037931
Receipt No. R000042663
Scientific Title Clinical evaluation of irAEs in ptients with ICI
Date of disclosure of the study information 2019/09/09
Last modified on 2020/02/01 (Ver. 2)

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Basic information
Public title Clinical evaluation of irAEs in ptients with ICI
Acronym Clinical evaluation of irAEs in ptients with ICI
Scientific Title Clinical evaluation of irAEs in ptients with ICI
Scientific Title:Acronym Clinical evaluation of irAEs in ptients with ICI
Region
Japan

Condition
Condition immune related adverse events
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate if pretreatment diabetes has any effect to mortality rate associated with irAEs in patients with non small cell lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes OS and PFS of DM and non DM
Key secondary outcomes the number of immune related adverse events

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
47 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria nothing
Key exclusion criteria nothing
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takahisa
Middle name
Last name Hirose
Organization Toho University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology
Zip code 1438541
Address 6-11-1, Oomorinishi , Otaku, Japan
TEL 0337624151
Email somu.omori@jim.toho-u.ac.jp

Public contact
Name of contact person
1st name Yasushi
Middle name
Last name Uchino
Organization Toho University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology
Zip code 1438541
Address 6-11-1, Oomorinishi , Otaku, Japan
TEL 0337624151
Homepage URL
Email somu.omori@jim.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine
Institute
Department

Funding Source
Organization no source
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Toho University School of Medicine
Address 6-11-1, Oomorinishi , Otaku, Japan
Tel 03-3762-4151
Email somu.omori@jim.toho-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 M19129
Org. issuing International ID_1 Toho University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 09 Month 09 Day

Related information
URL releasing protocol https://diabetes.diabetesjournals.org/content/68/Supplement_1/160-OR
Publication of results Unpublished

Result
URL related to results and publications https://diabetes.diabetesjournals.org/content/68/Supplement_1/160-OR
Number of participants that the trial has enrolled 88
Results 
Compared to the non-diabetes, diabetes has not been associated with irAEs risks for baseline characteristics and after propensity score matching analysis. During a mean follow-up of 30 months, overall (OS) and cancer specific progression free survival (PFS) were significantly improved in irAEs group. After propensity scores analyses, DM was significantly associated with increased risks of lower OS.
Results date posted
2020 Year 02 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
 Patients with lung cancer who were administered anti-PD-1 antibody between 1/Sep/2015 and 31/Jul/2018 were retrospectively enrolled and followed until 20/Jan/2018, collected from Toho University entire patients NEPTUNE database.
Participant flow 
All the patients with lung cancer who were treated with ICI were collected.They were followed untill their death, or moving to terminal hospital.
Adverse events 
None.
Outcome measures 
progression free survival, and overall survival were reserched.
Plan to share IPD We share data of the patients through UMIN.
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
2019 Year 09 Month 01 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2019 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2019 Year 09 Month 04 Day
Last modified on
2020 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042663