UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037931 |
|---|---|
| Receipt number | 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 18:59:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
somu.omori@jim.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042663
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
