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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013465
Receipt No. 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

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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
Email 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
Email iaoyang1@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015604

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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