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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029444
Receipt No. 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 2017/10/09

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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
Email 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
Email tomonobu@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 05 Day
Last follow-up date
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
2017 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033558

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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