UMIN-CTR Clinical Trial

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

Sponsor
Institute	Kyoto University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042968