UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036658 |
|---|---|
| Receipt number | R000041764 |
| Scientific Title | The treatment outcome for the colorectal neuroendocrine tumor: a multi-institutional retrospective study |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2019/05/06 15:19:34 |
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Basic information
Public title
The treatment outcome for the colorectal neuroendocrine tumor: a multi-institutional retrospective study
Acronym
The treatment outcome for the colorectal neuroendocrine tumor: a multi-institutional retrospective study
Scientific Title
The treatment outcome for the colorectal neuroendocrine tumor: a multi-institutional retrospective study
Scientific Title:Acronym
The treatment outcome for the colorectal neuroendocrine tumor: a multi-institutional retrospective study
Region
| Japan |
Condition
Condition
colorectal neuroendocrine tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will elucidate the risk factors of regional and distant metastasis, and assess the long term prognosis.
Basic objectives2
Others
Basic objectives -Others
This study will elucidate the risk factors of regional and distant metastasis, and assess the long term prognosis.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The regional/distant metastasis rate and the risk factors of the colorectal neuroendocrine tumor G1 / G2 based on the 2010 WHO classification.
Key secondary outcomes
1.Long-term prognosis (relapse-free survival, cancer-specific survival, overall survival) of large-scale neuroendocrine tumors G1 / G2
2. The relationship between the depth of submucosal invasion and lymph node metastasis of colorectal neuroendocrine tumor G1 / G2
3. The relationship between tumor budding grade and lymph node metastasis of colorectal neuroendocrine tumor G1/G2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who are histologically diagnosed with colorectal neuroendocrine tumor G1 and G2
Key exclusion criteria
Age <18 years
the cases not treated
the cases that died within 30 days after surgery
the cases having the combined other malignancies
the cases having incomplete clinicopathological data
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | keigo |
| Middle name | |
| Last name | chida |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama, Japan
TEL
+81-45-261-5656
o-o.ttt0123.s-k@outlook.jp
Public contact
Name of contact person
| 1st name | keigo |
| Middle name | |
| Last name | chida |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama, Japan
TEL
+81-45-261-5656
Homepage URL
https://www.yokohama-cu.ac.jp/amedrc/ethics/ethical/center_optout.html
o-o.ttt0123.s-k@outlook.jp
Sponsor or person
Institute
Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan
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
Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan
Address
4-57, Urafune-cho, Minami-ku, Yokohama, Japan
Tel
045-261-5656
o-o.ttt0123.s-k@outlook.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
B180700008
Org. issuing International ID_1
Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立市民病院(神奈川県)
NTT東日本関東病院(東京)
横須賀共済病院(神奈川県)
済生会横浜市南部病院(神奈川県)
横浜市立みなと赤十字病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.yokohama-cu.ac.jp/amedrc/ethics/ethical/center_optout.html
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
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 05 | Month | 06 | Day |
Last modified on
| 2019 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041764
