UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033544 |
|---|---|
| Receipt number | R000038250 |
| Scientific Title | Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2020/07/28 17:34:17 |
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Basic information
Public title
Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Acronym
Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Scientific Title
Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Scientific Title:Acronym
Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Region
| Japan |
Condition
Condition
Esophageal squamous cell carcinoma and achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota in patients with achalasia and esophageal squamous cell carcinoma.
Basic objectives2
Others
Basic objectives -Others
Esophageal microbiota before and after per-oral endoscopic myotomy in patients with achalasia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of esophageal microbiota on carcinogenesis of esophageal squamous cell carcinoma in patients with achalasia
Key secondary outcomes
Esophageal microbiota before and after per-oral endoscopic myotomy in patients with achalasia.
Comparison of esophageal microbiota between the patients with esophageal squamous cell carcinoma and the patients with achalasia
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patient who is older than 18 when the informed consent is obtained.
2. The patient who is diagnosed with achalasia or esophageal squamous cell carcinoma and is going to undergo endoscopic treatment in our hospital.
3. The performance status of the patients is 0, 1, or 2.
4. The patient whose informed consent is obtained.
Key exclusion criteria
1. The patient who is pregnant or performing breast feeding.
2. The patient who was registered in this study before.
3. The patient who has risks for bleeding after esophageal biopsy.
4. The patient who underwent gastrectomy before.
5. The patient who had past histories of cervical cancer or esophageal cancer treated by radiation.
6. The patient who are being treated for cancers in other organs
7. The patients who are judged by the investigators to be inappropriate participants in the trial.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Terai |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
025-227-2207
terais@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Takahashi |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
025-227-2207
Homepage URL
kazuya911@med.niigata-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
新潟大学医歯学総合病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 30 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we obtain esophageal specimens using a brush for biliary cytology via endoscopic forceps channel. we are going to perform 16S rRNA gene amplicon sequencing analysis in 5 patients with esophageal squamous cell carcinoma before endoscopic submucosal dissection and 15 patients with achalasia before and after per-oral endoscopic myotomy. We also investigate the relationship between inflammation of the esophageal epithelium and esophageal microbiota in these patients.
Management information
Registered date
| 2018 | Year | 07 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038250
