UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032116 |
|---|---|
| Receipt number | 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 13:10:22 |
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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
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
ohshima-t@fs.tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036639
| 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 |
