UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026506 |
|---|---|
| Receipt number | R000030441 |
| Scientific Title | clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2019/09/19 10:10:54 |
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Basic information
Public title
clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer
Acronym
Churaumi Study
Scientific Title
clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer
Scientific Title:Acronym
Churaumi Study
Region
| Japan |
Condition
Condition
Case with esophageal stricture following ESD treatment for early esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of transplanting an autologous oral mucosal epithelial cell sheet to the lacrimal injury arising when balloon dilation is performed against esophageal stricture after ESD treatment for early esophageal cancer and its effectiveness in preventing esophageal narrowing
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety of Oral Mucosal Epithelial Cell Sheet
Key secondary outcomes
Preventive effect of esophageal narrowing by oral mucosal epithelial cell sheet transplantation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Oral mucosa and peripheral blood are collected from the patient, an oral mucosa epithelial cell sheet is prepared from the collected oral mucosa and peripheral blood, and transplanted to a laceration site after balloon dilation using an endoscope
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) Patients aged 20 years or older.
2) Patients with esophageal stenosis that occurred after ESD treatment for early esophageal cancer.
3) Patients whose main organ function is kept as a rule as below (data within 1 month before registration).
Leukocyte count >= 4,000 <= 10,000
Platelet count >= 100,000
Serum AST (GOT) and ALT (GPT) <= 100
Serum total bilirubin <= 2.0
Serum creatinine <= 2.0
In the above, the inspection standard value of the currently practiced esophageal regeneration cell sheet trial was adopted. However, if it is considered that the reason for not satisfying the above is based on the original disease, it can be selected according to the judgment of the research representative.
Key exclusion criteria
1) Patients with complications of poor control
(Heart disease, liver disease, kidney disease, cerebral infarction, etc.).
2)Patients with pregnancy, lactating women and possibility (intention) of pregnancy.
3)A patient with a history of serious drug allergy.
4)Patients infected with infectious diseases (hepatitis B, hepatitis C, HIV, HTLV-1, syphilis).
5)A patient who has a disease in the oral mucosa at the tissue collection site and is unable to collect it.
6)Other patients who are deemed inappropriate by the research representative.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Atsunaga |
| Middle name | |
| Last name | Katou |
Organization
Tomishiro Central Hospital
Division name
Gastroenterology
Zip code
9010243
Address
25 aza ueda tomigusuku-shi okinawa prefecture
TEL
098-850-3811
akatou@yuuai.or.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ochiai |
Organization
Tomishiro Central Hospital
Division name
Advanced Medical Research Center
Zip code
9010243
Address
25 aza ueda tomigusuku-shi okinawa prefecture
TEL
098-850-3811
Homepage URL
ochiai.tomishirocentaral.hp@gmail.com
Sponsor or person
Institute
Tomishiro Central Hospital
Institute
Department
Personal name
Funding Source
Organization
okinawa prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Specific Regenerative Medicine Committee
Address
3-1-1 umade higasiku hukuoka-city
Tel
092-642-5082
byshasiwatas@jimu.kyushu-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
豊見城中央病院（沖縄県）、中頭病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030441
