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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024016
Receipt No. R000027450
Scientific Title Retrospective study about predictors for lymph node metastasis in T1 colorectal cancer
Date of disclosure of the study information 2016/10/01
Last modified on 2016/10/04

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Basic information
Public title Retrospective study about predictors for lymph node metastasis in T1 colorectal cancer
Acronym Predictors for lymph node metastasis in T1 colorectal cancer
Scientific Title Retrospective study about predictors for lymph node metastasis in T1 colorectal cancer
Scientific Title:Acronym Predictors for lymph node metastasis in T1 colorectal cancer
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Conducting multicenter research about predictors for lymph node metastasis in T1 colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of lymph node metastasis about T1 colorectal cancer in operation cases
Key secondary outcomes The rate of lymph node metastasis about several predictors(SM invasion depth, histological type, vascular invasion, budding)

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 T1 colorectal cancers with complete surgical resection
Key exclusion criteria cancer with stalk
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 0752515519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 0752515519
Homepage URL
Email naohisa@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Department of Molecular Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Fukuchiyama City Hospital
Ayabe city Hospital
North Medical Center Kyoto Prefectural University of Medicine
Matsushita Memorial Hospital
Murakami Hospital Asahi University
Nishijin Hospital
Kyoto City Hospital
Otsu Municipal Hospital
Kyoto Kujo Hospital
Nara City Hospital


Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 01 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective study

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027450

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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