UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036976 |
|---|---|
| Receipt number | R000042124 |
| Scientific Title | Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer. |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2020/06/05 10:31:25 |
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Basic information
Public title
Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Acronym
Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Scientific Title
Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Scientific Title:Acronym
Multi-institutional investigation: Biomarker identification for proper use of Nivolmab for head and neck cancer.
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Identification of a new biomarker of Nivolmab for head and neck cancer, by investigating the treatment response and analyzing gene mutation, gene mutation frequency and tumor microenvironment
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study to proper use of Nivolmab
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of a new biomarker of Nivolmab for head and neck cancer.
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
Patient with recurrent or metastatic head and neck cancer who recieved Nivolmab
Key exclusion criteria
Patient without the history of treatment of the chemotherapy including the platinum
Patient who received Nivolmab as adjuvant chemotherapy
The patient who received a combination with other anti-cancer agents
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Asakage |
Organization
Tokyo Medical and Dental University
Division name
Department of Head and Neck Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5913
tasakage@gmail.com
Public contact
Name of contact person
| 1st name | Kazuchika |
| Middle name | |
| Last name | Ohno |
Organization
Tokyo Medical and Dental University
Division name
Department of Head and Neck Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5913
Homepage URL
ohno.hns@tmd.ac.jp
Sponsor or person
Institute
Department of Head and Neck Surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
rec.adm@tmd.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Identification of a new biomarker of Nivolmab for head and neck cancer, by investigating the treatment response and analyzing gene mutation, gene mutation frequency and tumor microenviroment.
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2020 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042124
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
