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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name