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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041415
Receipt No. R000047209
Scientific Title A study of long-term prognosis after colorectal cancer surgery
Date of disclosure of the study information 2020/10/01
Last modified on 2020/08/14

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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
2020 Year 08 Month 14 Day


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

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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