UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040615 |
|---|---|
| Receipt number | 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 20:02:39 |
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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
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
bungohs@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046351
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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