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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032116
Receipt No. R000036639
Scientific Title Analysis of oral microbeta in oral and upper digestive tract cancer patients
Date of disclosure of the study information 2018/04/05
Last modified on 2018/04/05

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Basic information
Public title Analysis of oral microbeta in oral and upper digestive tract cancer patients
Acronym Analysis of oral microbeta in oral and upper digestive tract cancer patients
Scientific Title Analysis of oral microbeta in oral and upper digestive tract cancer patients
Scientific Title:Acronym Analysis of oral microbeta in oral and upper digestive tract cancer patients
Region
Japan

Condition
Condition Oral and upper digestive tract cancer
Classification by specialty
Gastroenterology Oral surgery Dental medicine
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is comparing oral microbiota in cancer patients(oral and upper digestive tract) and non-cancer patients,and analysis of the relationship to antimicrobial components and metabolites in saliva.
Basic objectives2 Others
Basic objectives -Others This study is comparing oral microbiota in cancer patients(oral and upper digestive tract) and non-cancer patients,and analysis of the relationship to antimicrobial components and metabolites in saliva.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fungal species,Microbiota,The number of fungi,
Concentration of each antimicrobial protein and antibody(Defensin,SLPI,Lactoferrin,Histatins,sIgA),Low-molecular substance
Key secondary outcomes Age,Sex,Histoey of present illnesss,Past medical History ,Oral examination

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Swab
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cancer patients(oral and upper digestive tract) and non-cancer patients.
Key exclusion criteria The people can not follow instructions ,low secretional capacity of saliva .

The people received chemotherapy and radiation.
The people were adoministrated antimicrobial agent up to 28days.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Ohshima
Organization Tsurumi University School of Dental Medicine
Division name Oral Microbiology
Zip code
Address 2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi,Kanagawa-ken 230-8051
TEL 045-580-8441
Email ohshima-t@fs.tsurumi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Ohshima
Organization Tsurumi University School of Dental Medicine
Division name Oral Microbiology
Zip code
Address 2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi,Kanagawa-ken 230-8051
TEL 045-580-8441
Homepage URL
Email ohshima-t@fs.tsurumi-u.ac.jp

Sponsor
Institute Tsurumi University
Institute
Department

Funding Source
Organization Tsurumi University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institutes of Biomedical Innovation, Health and Nutrition
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
2018 Year 04 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
2016 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 05 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036639

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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