UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008624 |
|---|---|
| Receipt number | R000010135 |
| Scientific Title | Methylene Blue-Assisted Lymph Node Dissection in Gastric Cancer Specimens |
| Date of disclosure of the study information | 2012/08/05 |
| Last modified on | 2018/01/08 19:37:20 |
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Basic information
Public title
Methylene Blue-Assisted Lymph Node Dissection in Gastric Cancer Specimens
Acronym
Methylene Blue-Assisted Lymph Node Dissection in Gastric Cancer Specimens
Scientific Title
Methylene Blue-Assisted Lymph Node Dissection in Gastric Cancer Specimens
Scientific Title:Acronym
Methylene Blue-Assisted Lymph Node Dissection in Gastric Cancer Specimens
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate the efficacy of methylene blue-assisted lymph node technique for LN assessment in gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
the ratio of the number of the harvested lymph nodes per time (minute)
Key secondary outcomes
the number of harvested lymph nodes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Histologically proven adenocarcinoma of the stomach.
(ii) Clinical stage1-3 disease.
(iii) R0 resection is acieved by gastrectomy with D1+ or D2 lymphadenectomy.
Key exclusion criteria
(i) Patients received any treatment before surgery.
(ii) Clinical Stage 4 disease.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikawa Takaki |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
Address
1-1-2 Nakao, Asahi-ku, Yokohama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
the Non-Governmental Organizations Kanagawa Standard Anti-cancer Therapy Support System
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The accrual was started in June 2012 and is to continue for 1 year.
Management information
Registered date
| 2012 | Year | 08 | Month | 05 | Day |
Last modified on
| 2018 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010135
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
