UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013465 |
|---|---|
| Receipt number | R000015604 |
| Scientific Title | Research for the development of acetaldehyde breath test to screen for risk subjects for HNSCC and ESCC |
| Date of disclosure of the study information | 2014/03/19 |
| Last modified on | 2016/10/11 15:25:35 |
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Basic information
Public title
Research for the development of acetaldehyde breath test to screen for risk subjects for HNSCC and ESCC
Acronym
acetaldehyde breath test to screen for risk subjects for HNSCC and ESCC
Scientific Title
Research for the development of acetaldehyde breath test to screen for risk subjects for HNSCC and ESCC
Scientific Title:Acronym
acetaldehyde breath test to screen for risk subjects for HNSCC and ESCC
Region
| Japan |
Condition
Condition
healthy volunteer
esophageal cancer
head and neck cancer
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
discern ALDH2 alleles through use of breath test
Basic objectives2
Others
Basic objectives -Others
investigation
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
discriminant accuracy of ALDH2 alleles
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The subject who has intention to participate in this study, and signed informed consent
2. Male and female subjects of >=20
3. The subject who is judged by clinical investigator by mean of physical examination or laboratory test to be eligible as a participant in this study
Key exclusion criteria
1. Pregnant or woman who has a chance of pregnant
2. The subject who has alcohol intolerance
3. The subject who is judged by clinical investigator to be inappropriate as a participant in this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto University Hospital
Division name
Department of Therapeutic Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku. Kyoto, Japan
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Aoyama |
Organization
Kyoto University Hospital
Division name
Department of Therapeutic Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku. Kyoto, Japan
TEL
075-751-3518
Homepage URL
iaoyang1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 03 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | 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
| 2014 | Year | 03 | Month | 19 | Day |
Last modified on
| 2016 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015604
