UMIN-CTR Clinical Trial

Basic information
Public title	A study of long-term prognosis after colorectal cancer surgery
Acronym	A study of long-term prognosis after colorectal cancer surgery
Scientific Title	A study of long-term prognosis after colorectal cancer surgery
Scientific Title:Acronym	A study of long-term prognosis after colorectal cancer surgery
Region	Japan

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

Objectives
Narrative objectives1	To study the long-term outcomes of patients with colorectal cancer 10 years after surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	10-year survival rate
Key secondary outcomes	cause of death other disease health condition body weight Quality of life economic status

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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients treated for colorectal cancer at the General Southern Tohoku Hospital between January 2004 and December 2009.
Key exclusion criteria	Those who did not consent to the study.
Target sample size	625

Research contact person
Name of lead principal investigator	1st name Yujiro Middle name Last name Nakayama
Organization	Southern Tohoku General Hospital
Division name	Surgery
Zip code	963-8052
Address	Yatsuyamada 7-115, Koriyama, Fukushima
TEL	024-934-5322
Email	nakayama.fd3s@gmail.com

Public contact
Name of contact person	1st name Yujiro Middle name Last name Nakayama
Organization	Southern Tohoku General Hospital
Division name	Surgery
Zip code	963-8052
Address	Yatsuyamada 7-115, Koriyama, Fukushima
TEL	024-934-5322
Homepage URL
Email	nakayama.fd3s@gmail.com

Sponsor
Institute	Southern Tohoku General Hospital
Institute
Department

Funding Source
Organization	Southern Tohoku General Hospital
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	Southern Tohoku Research Institute for Neuroscience
Address	Yatsuyamada 7-115, Koriyama, Fukushima
Tel	024-934-5322
Email	nakayama.fd3s@gmail.com

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	2020 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	625
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	2019 Year 08 Month 20 Day
Date of IRB	2019 Year 10 Month 03 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2020 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Long-Term Outcomes of Patients with Colorectal Cancer 10 Years After Treatment in a Medium-Sized City Hospital (Observational Study)

Management information
Registered date	2020 Year 08 Month 14 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047209