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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036658
Receipt No. 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

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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
Email 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
Email o-o.ttt0123.s-k@outlook.jp

Sponsor
Institute Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041764

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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