UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry	2020 Year 02 Month 01 Day
Date trial data considered complete	2020 Year 03 Month 01 Day
Date analysis concluded	2020 Year 04 Month 01 Day

Other
Other related information	retrospective study

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2021 Year 09 Month 26 Day

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