UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024016 |
|---|---|
| Receipt number | R000027450 |
| Scientific Title | Retrospective study about predictors for lymph node metastasis in T1 colorectal cancer |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2021/09/26 22:30:39 |
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Basic information
Public title
Retrospective study about predictors for lymph node metastasis in T1 colorectal cancer
Acronym
Predictors for lymph node metastasis in T1 colorectal cancer
Scientific Title
Retrospective study about predictors for lymph node metastasis in T1 colorectal cancer
Scientific Title:Acronym
Predictors for lymph node metastasis 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
Conducting multicenter research about predictors for lymph node metastasis in T1 colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of lymph node metastasis about T1 colorectal cancer in operation cases
Key secondary outcomes
The rate of lymph node metastasis about several predictors(SM invasion depth, histological type, vascular invasion, budding)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
T1 colorectal cancers with complete surgical resection
Key exclusion criteria
cancer with stalk
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohisa Yoshida |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Department of Molecular Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuchiyama City Hospital
Ayabe city Hospital
North Medical Center Kyoto Prefectural University of Medicine
Matsushita Memorial Hospital
Murakami Hospital Asahi University
Nishijin Hospital
Kyoto City Hospital
Otsu Municipal Hospital
Kyoto Kujo Hospital
Nara City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 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
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027450
