UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037677 |
|---|---|
| Receipt number | R000042968 |
| Scientific Title | Study on the relationship between the breath acetaldehyde/ethanol ratio and the risk of Head and Neck/Esophageal cancer |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2022/03/18 20:55:43 |
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Basic information
Public title
Study on the relationship between the breath acetaldehyde/ethanol ratio and the risk of Head and Neck/Esophageal cancer
Acronym
Breath AERO-E study
Scientific Title
Study on the relationship between the breath acetaldehyde/ethanol ratio and the risk of Head and Neck/Esophageal cancer
Scientific Title:Acronym
Breath AERO-E study
Region
| Japan |
Condition
Condition
Esophageal cancer
Head and Neck cancer
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study clarifies the usefulness of the concentration ratio of acetaldehyde and ethanol calculated from exhaled gas after ingesting a small amount of ethanol as a new means of investigating the risk of head and neck / esophageal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between A/E ratio in expired air and Lugol-voiding lesions grade
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)diagnosed with head and neck cancer, esophageal cancer, gastric cancer, or suspected of having the disease, and scheduled to undergo endoscopy (iodine staining) for detailed examination and follow up after treatment
2)over 20 years old
3)clinical laboratory values meet the following standards
AST, ALT, GGTP Less than twice the facility standard upper limit of the research institution
4)obtain written consent from the subject
Key exclusion criteria
1)allergic to alcohol
2)allergic to iodine
3)pregnant or may be pregnant or breastfeeding
4)serious complications (such as chronic obstructive pulmonary disease that requires oxygen inhalation, pulmonary fibrosis, symptomatic heart failure)
5)history of bronchial asthma, drug allergies, etc.
6)history of cancer treatment other than endoscopic treatment
7)history of resection of the esophagus, stomach, liver, pancreas (excluding endoscopic treatment)
8)stricture in esophagus
9)judged inappropriate by the attending physician
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Kyoto University Hospital
Division name
Department of Clinical Oncology
Zip code
606-8507
Address
54kawahara-cho, shogoin, sakyo-ku, Kyoto
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kondo |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Therapeutic Oncology
Zip code
606-8507
Address
54kawahara-cho, shogoin, sakyo-ku, Kyoto
TEL
075-751-4592
Homepage URL
ykondo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
KUBIX Inc.
Nissha Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate school and Faculty of Medicine, Kyoto University Hospital, Ethics Committe
Address
yoshidakonoecho, sakyoku, kyoto city
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2019 | Year | 08 | Month | 13 | 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
| 2019 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items
1)Alcohol, tobacco and meal questionnaire
2)Genetic testing
3)Breath gas test
4)Endoscopic image
Management information
Registered date
| 2019 | Year | 08 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042968
