UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027922 |
|---|---|
| Receipt number | R000031983 |
| Scientific Title | Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2018/01/04 23:10:48 |
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Basic information
Public title
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Acronym
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Scientific Title
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Scientific Title:Acronym
Mulutiinstitutional study of Rapid-immunochemihistry (R-IHC) for lung tumor intraoperative diagnosis
Region
| Japan |
Condition
Condition
lung tumor
Classification by specialty
| Chest surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validate the usefulness of Rapid Immunohistchemistry staining Device (R-IHC) in intraoperative diagnosis of lung tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of Rapid Immunohistchemistry staining Device (R-IHC)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Lung tumor case requiring rapid intraoperative diagnosis
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Minamiya |
Organization
Akita university
Division name
Department of thoracic surgery
Zip code
Address
Hondo 1-1-1, Akita city, Akita, Japan
TEL
018-884-6132
minamiya@jd6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayato Konno |
Organization
Akita university
Division name
Department of thoracic surgery
Zip code
Address
Hondo 1-1-1, Akita city, Akita, Japan
TEL
018-884-6132
Homepage URL
konno-h@gipc.akita-u.ac.jp
Sponsor or person
Institute
Department of thoracic surgery, Akita university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe university, Iwate medical university, Tokyo medical university, Sndai kousei 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
秋田大学病院（秋田県）、神戸大学病院（兵庫県）、岩手医科大学病院（岩手県）、東京医科大学病院（東京都）、仙台厚生病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration has started.
Management information
Registered date
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031983
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
