UMIN-CTR Clinical Trial

Basic information
Public title	Clinicopathological features of rectal cancer according to the location
Acronym	Clinicopathological features of rectal cancer according to the location
Scientific Title	Clinicopathological features of rectal cancer according to the location
Scientific Title:Acronym	Clinicopathological features of rectal cancer according to the location
Region	Japan

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

Objectives
Narrative objectives1	To compare the clinicopathological features of rectal cancers according to the location
Basic objectives2	Others
Basic objectives -Others	To identify biological differences of rectal cancers according to the location
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lymph node metastasis
Key secondary outcomes	Age, gender, tumor size, morphology, recurrence rate, invasion rate, vessel permeation, tumor budding, wel or mod/ por or muc component, etc

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.T1 or T2 rectal cancer 2.Patients who received complete treatment for rectal cancer with surgical resection 3.Written informed consent
Key exclusion criteria	1.Presence of synchronous or metachronous advanced colorectal cancer 2.Presence of malignant diseases in any other organs
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name KATSURO ICHIMASA
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
Zip code
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL	045-949-7000
Email	ichitommy14@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name KATSURO ICHIMASA
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
Zip code
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL	045-949-7000
Homepage URL
Email	ichitommy14@yahoo.co.jp

Sponsor
Institute	Digestive Disease Center, Showa University Nothern Yokohama Hospital
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
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	2013 Year 10 Month 15 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	200
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	Terminated
Date of protocol fixation	2013 Year 07 Month 08 Day
Date of IRB	2013 Year 07 Month 08 Day
Anticipated trial start date	2013 Year 10 Month 15 Day
Last follow-up date	2022 Year 10 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective study

Management information
Registered date	2013 Year 10 Month 06 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013983