UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026206 |
|---|---|
| Receipt number | R000030104 |
| Scientific Title | Evaluation of viability of exfoliated tumor cells in intraluminal lavage after colorectal endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2021/02/28 17:50:51 |
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Basic information
Public title
Evaluation of viability of exfoliated tumor cells in intraluminal lavage after colorectal endoscopic submucosal dissection.
Acronym
Evaluation of viability of exfoliated tumor cells in intraluminal lavage after colorectal endoscopic submucosal dissection.
Scientific Title
Evaluation of viability of exfoliated tumor cells in intraluminal lavage after colorectal endoscopic submucosal dissection.
Scientific Title:Acronym
Evaluation of viability of exfoliated tumor cells in intraluminal lavage after colorectal endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of viability of exfoliated tumor cells after colorectal endoscopic submucosal dissection.
Basic objectives2
Others
Basic objectives -Others
Exfoliated tumor cells of intraluminal lavage after colorectal endoscopic submucosal dissection.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Viability of exfoliated tumor cells of intraluminal lavage (beginning of lavage) colorectal endoscopic submucosal dissection.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of colorectal tumors resected en bloc by endoscopic submucosal dissection.
Key exclusion criteria
Cases of incapacity decided by attending physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ueda |
Organization
Nara Medical University
Division name
Departments of Surgery
Zip code
643-8522
Address
840 Shijocho Kashihara,Nara,Japan
TEL
0744-22-3051
takeueda@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ueda |
Organization
Nara Medical University
Division name
Departments of Surgery
Zip code
634-8522
Address
840 Shijocho Kashihara, Nara
TEL
0744-22-3051
Homepage URL
takeueda@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Nara Medical Universtity
Address
840 Shijocho Kashihara, Nara
Tel
0744-22-3051
ychiken@naramed-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
| 2017 | Year | 02 | Month | 20 | 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 | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational trial
Management information
Registered date
| 2017 | Year | 02 | Month | 18 | Day |
Last modified on
| 2021 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030104
