UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of oral microbeta in oral and upper digestive tract cancer patients
Title of the study (Brief title)	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	Tomoko Ohshima
Organization	Tsurumi University School of Dental Medicine
Division name	Oral Microbiology
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	Tomoko Ohshima
Organization	Tsurumi University School of Dental Medicine
Division name	Oral Microbiology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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