UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028815 |
|---|---|
| Receipt number | R000032984 |
| Scientific Title | Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2019/05/23 16:15:03 |
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Basic information
Public title
Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Acronym
Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Scientific Title
Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Scientific Title:Acronym
Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to support determination of the optimal lymph node dissection range by grasping detailed distribution status of lymph flow and metastatic lymph nodes in colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of extent of lymph node metastasis (distance in axial direction of the intestinal tract, relationship with feeding vessel, central side)
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
Primary colon cancer patient diagnosed histologically as adenocarcinoma.
Preoperative StageII-IV Colorectal Cancer Patient.
Key exclusion criteria
Have double cancer. However, only for metachronous double cancer with a disease-free period longer than 5 years, registration is permitted.
Those with a history of operation affecting the colorectal cancer operation.
Those with a history of hypersensitivity to ICG and iodine.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryohei Sakamoto |
Organization
Fukuoka University School of Medicine
Division name
Gastroenterological surgery
Zip code
Address
7 - 45 - 1 Nagakuma, Seongnam-gu, Fukuoka city, Fukuoka prefecture
TEL
092-801-1101
skmt19790907@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Sakamoto |
Organization
Fukuoka University School of Medicine
Division name
Gastroenterological surgery
Zip code
Address
7 - 45 - 1 Nagakuma, Seongnam-gu, Fukuoka city, Fukuoka prefecture
TEL
092-801-1101
Homepage URL
skmt19790907@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Fukuoka University School of Medicine
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
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
| 2017 | Year | 09 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2017 | 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
none
Management information
Registered date
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032984
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
