UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020230 |
|---|---|
| Receipt number | R000023333 |
| Scientific Title | Usefulness of oral health care for perioperative thoracic esophageal cancer -prospective non-randomized trial |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2019/12/12 19:31:42 |
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Basic information
Public title
Usefulness of oral health care for perioperative thoracic esophageal cancer
-prospective non-randomized trial
Acronym
Trial for usefulness of oral care in thoracic esophageal cancer
Scientific Title
Usefulness of oral health care for perioperative thoracic esophageal cancer
-prospective non-randomized trial
Scientific Title:Acronym
Trial for usefulness of oral care in thoracic esophageal cancer
Region
| Japan |
Condition
Condition
Thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To estimate efficacy of oral health care in perioperative thoracic esophageal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate acetaldehyde production from oral microbiota.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
oral health care for perioperative thoracic esophageal cancer
Interventions/Control_2
oral health care for healthy controls
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Thoracic esophageal cancer
(2) Clinical stage
(T1aN1M0, T1bN0M0)
(T1aN2M0, T1bN1M0, T1bN2M0,T2N0M0, T2N1M0,
T3N0M0)
(T3N1M0, T3N2M0, T3N3M0, T4N0M0)
(3) ECOG Performance Status Scale:0,1
(4) Age: 20-80 years old
(5) Signed informed consent
Key exclusion criteria
(1) Active concomitant malignancy
(2) Adults without sufficient judgement capacity
(3) Other conditions judged ineligible by physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Tanda |
Organization
Tohoku University Hospital
Division name
Department of Preventive Dentistry
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-8330
ntanda@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Tanda |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Preventive Dentistry
Zip code
Address
Seiryo-machi 4-1, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-8328
Homepage URL
ntanda@m.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 12 | Month | 24 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe acetaldehyde production from oral microbiota, acetaldehyde from mouth air and breath, and number of oral microbiota in saliva before and after oral care.
We also examine Genotype of ADH1B and ALDH2.
Twenty patients and 20 healthy subjects as control are observed.
Management information
Registered date
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023333
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
