UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034027 |
|---|---|
| Receipt number | R000038532 |
| Scientific Title | Assessment of usefulness of Endocytoscopy for biopsy specimens of medical thoracoscopy |
| Date of disclosure of the study information | 2018/09/06 |
| Last modified on | 2018/09/03 18:20:06 |
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Basic information
Public title
Assessment of usefulness of Endocytoscopy for biopsy specimens of medical thoracoscopy
Acronym
Usefulness of Endocytoscopy for biopsy specimens of medical thoracoscopy
Scientific Title
Assessment of usefulness of Endocytoscopy for biopsy specimens of medical thoracoscopy
Scientific Title:Acronym
Usefulness of Endocytoscopy for biopsy specimens of medical thoracoscopy
Region
| Japan |
Condition
Condition
Pleural diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether diagnosis of malignant finding is possible using ECS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic yield using ECS.
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
1)For diagnosis of pleural disease, patients planning thoracoscopy.
2)informed concent.
Key exclusion criteria
clinical difficulties in the trial.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Shiratsuki |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2580
shira166@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Shiratsuki |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2580
Homepage URL
shira166@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2018 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038532
