UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028004 |
|---|---|
| Receipt number | R000032070 |
| Scientific Title | Unraveling the pathogenesis and relationship among manometric subtype of esophageal achalasia and achalasia-related disease, using cytokine profile expressed in the muscle layer |
| Date of disclosure of the study information | 2017/06/29 |
| Last modified on | 2017/06/29 17:35:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Unraveling the pathogenesis and relationship among manometric subtype of esophageal achalasia and achalasia-related disease, using cytokine profile expressed in the muscle layer
Acronym
Unraveling the pathogenesis and relationship among manometric subtype of esophageal achalasia using cytokine profile expressed in the muscle layer
Scientific Title
Unraveling the pathogenesis and relationship among manometric subtype of esophageal achalasia and achalasia-related disease, using cytokine profile expressed in the muscle layer
Scientific Title:Acronym
Unraveling the pathogenesis and relationship among manometric subtype of esophageal achalasia using cytokine profile expressed in the muscle layer
Region
| Japan |
Condition
Condition
Esophageal achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pathogenesis and the relationship among esophageal achalasia subtype
Basic objectives2
Others
Basic objectives -Others
Unraveling the pathogenesis
Associated factor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The expression of cytokine and transcription factor related to Th1/Th2/Th17 immunological response in esophageal achalasia and achalasia-related disease
Key secondary outcomes
The relationship between achalasia subtype and the pattern of cytokine expression in esophageal muscle layer
The relationship between achalasia subtype and the esophageal / intestinel flora
Pathological diference among esophageal achalasia subtype
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 esophageal achalasia and achalasia-related disease
Patients who are aged 20 years or older at the time of acquisition
Key exclusion criteria
Patients who reject this research
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eikichi Ihara |
Organization
Graduate school of Medical Sciences, Kyushu Universit
Division name
Department of Medicine and Bioregulatory
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5286
eikichi@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eikichi Ihara, Koji Mukai |
Organization
Graduate school of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5286
Homepage URL
eikichi@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Digestive Disease Center, Showa University koto Toyosu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient group:
We collect the biopsy samples of mucosal and muscular tissues from patients with achalasia, and obtain the stools to analyze gut bacterial flora.
Control group 1:
We collect the biopsy samples of mucosal and muscular tissues from patients with esophageal cancer during esophagectomy.
Control group 2:
We collect the biopsy samples of mucosal tissues from patients without esophageal motility disorder, and obtain the stools to analyze gut bacterial flora.
Management information
Registered date
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032070
