UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038051 |
|---|---|
| Receipt number | R000030434 |
| 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 | 2019/09/19 |
| Last modified on | 2019/09/19 10:13:36 |
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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
Esophageal narrowing after ESD
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 for the laceration that occurs when the balloon dilation is performed against esophageal stricture after ESD treatment for early esophageal cancer and its effectiveness for prevention of esophageal constriction
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Transplant an autologous oral mucosal epithelial cell sheet into the laceration that occurs when balloon dilatation is performed for esophageal stricture
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 over 20 years of age.
2) Patients with esophageal stricture that occurred after ESD treatment for early esophageal cancer.
3) In principle, patients whose major organ functions are maintained as follows
(Data within one month before registration).
White blood cell count > 4,000 / uL, < 10,000 / uL
Platelet count > 100,000 / uL
Serum AST (GOT) and ALT (GPT) < 100 IU / L
Serum total bilirubin < 2.0mg / dL
Serum creatinine < 2.0mg / dL
However, if it is considered that the reason for not satisfying the above is based on the primary disease, it can be selected at the discretion of the principal investigator.
4) Patients with written consent.
5) For women: Surgery, radiation, or menopause can rule out the possibility of pregnancy, or the use of approved contraceptive methods can reduce the chance of pregnancy from the start of the study to the end of the study.
Key exclusion criteria
I) Patients with complications of poor control
(Heart disease, liver disease, kidney disease, cerebral infarction, etc.).
I) Pregnancy, breastfeeding, and patients with the possibility of pregnancy (will).
I) Patients with a history of severe drug allergies.
Ii) Patients infected with infectious diseases (hepatitis B, hepatitis C, HIV, HTLV-1, syphilis).
I) Patients who have a disease in the oral mucosa of the tissue collection site and cannot be collected.
Ii) Other patients who are judged inappropriate by the principal investigator.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Atsunaga |
| Middle name | |
| Last name | Katou |
Organization
Gastroenterology
Division name
Gastroenterology
Zip code
9010243
Address
25 ueda tomidusuku-shi okinawa
TEL
098-850-3811
akatou@yuuai.or.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ochiai |
Organization
Advanced Medical Research Center
Division name
Advanced Medical Research Center
Zip code
9010243
Address
25 ueda tomidusuku-shi okinawa
TEL
098-850-3811
Homepage URL
ochiai.tomishirocentral.hp@gmail.com
Sponsor or person
Institute
okinawa prefecture
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.kyushuu.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
| 2019 | Year | 09 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 19 | 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=R000030434
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
