UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002373 |
|---|---|
| Receipt number | R000002917 |
| Scientific Title | Establishment of Rapid Intraoperative Detection of Lymph Node metastasis Using Molecularbiological Method |
| Date of disclosure of the study information | 2009/08/24 |
| Last modified on | 2023/09/04 14:31:24 |
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Basic information
Public title
Establishment of Rapid Intraoperative Detection of Lymph Node metastasis Using Molecularbiological Method
Acronym
Establishment of Rapid Intraoperative Detection of Lymph Node metastasis Using Molecularbiological Method
Scientific Title
Establishment of Rapid Intraoperative Detection of Lymph Node metastasis Using Molecularbiological Method
Scientific Title:Acronym
Establishment of Rapid Intraoperative Detection of Lymph Node metastasis Using Molecularbiological Method
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Detection of micrometastasis fo lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis
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
lung cancer
Key exclusion criteria
chilidren
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Shiraishi |
Organization
Kumamoto University Hospital
Division name
Thoracic surgery
Zip code
8608556
Address
Honjo 1-1-1 Kumamoto Chuo-ku
TEL
096-373-5533
shiraken@wb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Shiraishi |
Organization
Kumamoto University
Division name
Sensiniryotantou
Zip code
8608556
Address
Honjo 1-1-1 Kumamoto Chuo-ku, Kumamoto Japan
TEL
096-373-5533
Homepage URL
shiraken@wb3.so-net.ne.jp
Sponsor or person
Institute
Kumamoto University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kakenhi
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University School of Medicine
Address
Honjo 1-1-1 Kumamoto Chuo-ku, Kumamoto Japan
Tel
096-373-5965
f-ogata@jimu.kumamoto-u.ac.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
| 2009 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
Finished
Number of participants that the trial has enrolled
20
Results
Finished
Results date posted
| 2023 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Finished
Participant flow
Finished
Adverse events
Finished
Outcome measures
Finished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2009 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prognosis
Management information
Registered date
| 2009 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002917
