UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033626 |
|---|---|
| Receipt number | R000038327 |
| Scientific Title | Examination of histological diagnosis by ultra-thin bronchoscopic findings |
| Date of disclosure of the study information | 2018/08/03 |
| Last modified on | 2022/09/16 19:26:51 |
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Basic information
Public title
Examination of histological diagnosis by ultra-thin bronchoscopic findings
Acronym
observation of XP260F
Scientific Title
Examination of histological diagnosis by ultra-thin bronchoscopic findings
Scientific Title:Acronym
observation of XP260F
Region
| Japan |
Condition
Condition
peripheral pulmonary lesion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe the endobronchial findings of the peripheral pulmonary lesions using a ultra-thin bronchoscope.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
endobronchial findings
Key secondary outcomes
The relationship between the findings and the histopathological diagnosis of the peripheral pulmonary lesion, the bronchoscope advanced at generation of bronchial branching, assessment of usefulness of physiological saline injection(intra-observer agreement, inter-observer agreement)
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)Patiants need to undergo diagnostic bronchoscopy
2) A case in which the bronchus(internal diamater less than 4mm) is reaching in to the lesion on HR-CT.
3) 20 years old or more
4)informed concent
Key exclusion criteria
clinical difficulties in the trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Nakao |
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
mika14@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Nakao |
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
mika14@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 | 08 | Month | 03 | 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 | 05 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
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 | 08 | Month | 03 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038327
