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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040615
Receipt No. R000046351
Scientific Title Aldehyde breath test as a disease marker in patients with esophageal and hypopharyngeal squamous cell carcinoma
Date of disclosure of the study information 2020/06/01
Last modified on 2020/06/01

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Basic information
Public title Aldehyde breath test as a disease marker in patients with digestive disease
Acronym Aldehyde breath test as a disease marker in patients with digestive diseas
Scientific Title Aldehyde breath test as a disease marker in patients with esophageal and hypopharyngeal squamous cell carcinoma
Scientific Title:Acronym Aldehyde breath test as a disease marker in patients with esophageal and hypopharyngeal squamous cell carcinoma
Region
Japan

Condition
Condition Digestive disease
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze the relationship between digestive diseases and ALDH2 gene polymorphisms, we will measure the trace amount of acetaldehyde / ethanol in the exhaled breath samples.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ALDH2 gene polymorphism in digestive diseases
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 Patients with digestive disorders over the age of 20
Patients examined in a medical checkup over the age of 20
Key exclusion criteria (1) history of surgical resection of any part of the upper gastrointestinal tract, (2) history of alcohol allergy, (3) age below 20 years, (4) current pregnancy.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Ido
Organization Digestive and Lifestyle Diseases
Division name Department of Human and Environmental Sciences
Zip code 8908544
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 099-275-5326
Email ido-akio@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Fumisato
Middle name
Last name Sasaki
Organization Digestive and Lifestyle Diseases
Division name Department of Human and Environmental Sciences
Zip code 890-8544
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 099-275-5326
Homepage URL
Email bungohs@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kagoshima University Hospital Clinical Research Ethics Committee
Address 8-35-1 Sakuragaoka, Kagoshima
Tel 099-275-6624
Email crmc@m2.kufm.kagoshima-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
2020 Year 06 Month 01 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
2016 Year 11 Month 10 Day
Date of IRB
2016 Year 11 Month 10 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2020 Year 06 Month 01 Day
Last modified on
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046351

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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