UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023955 |
|---|---|
| Receipt number | R000027575 |
| Scientific Title | The risk factor of recurrence in T1 colorectal cancer |
| Date of disclosure of the study information | 2016/09/06 |
| Last modified on | 2021/02/23 14:06:20 |
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Basic information
Public title
The risk factor of recurrence in T1 colorectal cancer
Acronym
The risk factor of recurrence in T1 colorectal cancer
Scientific Title
The risk factor of recurrence in T1 colorectal cancer
Scientific Title:Acronym
The risk factor of recurrence 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
To investigate the clinicopathological risk factors of recurrence in T1 colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
To investigate the risk factors of recurrence in T1 colorectal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence
Key secondary outcomes
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.Patients who received complete treatment for submucosal invasive colorectal cancer with endoscopic resection or surgical resection
2.Written informed consent
Key exclusion criteria
1.Presence of synchronous or metachronous advanced colorectal cancer
2.Patients with inflammatory bowel disease
3.Hereditary colorectal cancer
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kouyama |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL
045-949-7000
kouyuta1101@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kouyama |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL
045-949-7000
Homepage URL
kouyuta1101@yahoo.co.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital Digestive Disease Center
Institute
Department
Personal name
Funding Source
Organization
Showa University Northern Yokohama Hospital Digestive Disease Center
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
Showa University Northern Yokohama Hospital
Address
35-1, Chigasaki-Chuo Tsuzuki-ku, Yokohama-shi
Tel
0459497000
kouyuta1101@yahoo.co.jp
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 | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29748707/
Number of participants that the trial has enrolled
930
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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | 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
| 2016 | Year | 09 | Month | 06 | Day |
Last modified on
| 2021 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027575
