UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029444 |
|---|---|
| Receipt number | R000033558 |
| Scientific Title | Predictive biomarker analysis for clinical outcome in cancer patients using salivary cytokines |
| Date of disclosure of the study information | 2017/10/05 |
| Last modified on | 2021/04/08 10:46:12 |
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Basic information
Public title
Predictive biomarker analysis for clinical outcome in cancer patients using salivary cytokines
Acronym
Salivary cytokines analysis
Scientific Title
Predictive biomarker analysis for clinical outcome in cancer patients using salivary cytokines
Scientific Title:Acronym
Salivary cytokines analysis
Region
| Japan |
Condition
Condition
non-small cell lung cancer, head and neck cancer, renal cell carcinoma, gastric cancer
Classification by specialty
| Medicine in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To see relationship between therapeutic response and salivary cytokines dynamics
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salivary cytokine panel and therapeutic response
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
non-small cell lung cancer, renal cell carcinoma, head and neck tumor
Key exclusion criteria
sotomatitis
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonobu Koizumi |
Organization
Shinshu University
Division name
Comprehensive Cancer Therap, Medical School of Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2554
tomonobu@shinshu-u.ac.jo
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonobu Koizumi |
Organization
Shinshu University
Division name
Comprehensive Cancer Therap, Medical School of Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2554
Homepage URL
tomonobu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ono Pahrmacological Co.,Ltd. / Bristol-Meyrs Squibb K.K.
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
Address
Tel
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
| 2017 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033558
