UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043210 |
|---|---|
| Receipt number | R000049234 |
| Scientific Title | Clinical utility of endoscopic resection for the treatment of rectal neuroendocrine tumors: a retrospective cohort study |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2023/02/02 10:48:54 |
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Basic information
Public title
Clinical utility of endoscopic resection for the treatment of rectal neuroendocrine tumors: a retrospective cohort study
Acronym
Utility of endoscopic resection for the treatment of rectal
neuroendocrine tumors
Scientific Title
Clinical utility of endoscopic resection for the treatment of rectal neuroendocrine tumors: a retrospective cohort study
Scientific Title:Acronym
Utility of endoscopic resection for the treatment of rectal
neuroendocrine tumors
Region
| Japan |
Condition
Condition
Rectal neuroendocrine neoplasm (NEN)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of endoscopic resection for the treatment of rectal NEN and to evaluate long-term outcomes after endoscopic treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival and recurrence rates
Key secondary outcomes
Complete resection rate, procedure time, complication rate (perforation, bleeding), complete resection rate by endoscopic submucosal dissection
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
Patients with rectal NEN
Key exclusion criteria
1. Patients < 20 year-old
2. Patients who are considered as inappropriate by doctors
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Hamada |
Organization
Mie University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL
059-231-5017
y-hamada@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Hamada |
Organization
Mie University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL
059-231-5017
Homepage URL
y-hamada@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University Hospital
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
The Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie, 514-8507, Japan
Tel
059-231-5045
s-kenkyu@mo.medic.mie-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
| 2021 | Year | 02 | Month | 10 | 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
150
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
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 04 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 02 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 02 | Day |
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049234
| Research Plan | |
|---|---|
| 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 |
