UMIN-CTR Clinical Trial

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
Last 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
1st 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