UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041415 |
|---|---|
| Receipt number | 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 | 2021/08/19 06:00:10 |
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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
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
nakayama.fd3s@gmail.com
Sponsor or person
Institute
Southern Tohoku General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047209
