UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034302 |
|---|---|
| Receipt number | R000039031 |
| Scientific Title | Follow-up survey of nivolumab, pembrolizumab and ipilimumab in Sapporo City General Hospital |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/09/30 17:00:38 |
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Basic information
Public title
Follow-up survey of nivolumab, pembrolizumab and ipilimumab in Sapporo City General Hospital
Acronym
Follow-up survey of nivolumab, pembrolizumab and ipilimumab in our institute
Scientific Title
Follow-up survey of nivolumab, pembrolizumab and ipilimumab in Sapporo City General Hospital
Scientific Title:Acronym
Follow-up survey of nivolumab, pembrolizumab and ipilimumab in our institute
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer, malignant melanoma, head and neck cancer, gastric cancer, renal cell cancer, urothelial carcinoma, Hodgkin lymphoma
Classification by specialty
| Gastroenterology | Pneumology | Hematology and clinical oncology |
| Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigated implementation status of prescreening in patients treated with immune checkpoint inhibitors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune-related adverse events
Key secondary outcomes
Response rate, Overall survival
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient administered nivolumab, pembrolizumab or ipilimumab
Key exclusion criteria
The case that the dosage situation and side effect information of nivolumab, pembrolizumab or ipilimumab cannot confirm from a medical record enough
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sone |
| Middle name | |
| Last name | Takayuki |
Organization
Sapporo City General Hospital
Division name
Department of Gastroenterology
Zip code
060-8604
Address
1-1 Kita 13 Nishi 11, Chuo-ku, Sapporo, Japan
TEL
011-726-2211
takakikyou@gmail.com
Public contact
Name of contact person
| 1st name | Sone |
| Middle name | |
| Last name | Takayuki |
Organization
Sapporo City General Hospital
Division name
Department of Gastroenterology
Zip code
0608604
Address
1-1 Kita 13 Nishi 11, Chuo-ku, Sapporo, Japan
TEL
011-726-2211
Homepage URL
takakikyou@gmail.com
Sponsor or person
Institute
Sapporo City General Hospital
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
Sapporo City General Hospital
Address
1-1 Kita 13 Nishi 11, Chuo-ku, Sapporo, Japan
Tel
011-726-2211
ho.shomu@city.sapporo.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
77
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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In periods from September, 2014 to June, 2018
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2019 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039031
