UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032880
Receipt number R000037454
Scientific Title Retrospective study of factors in diagnosis by means of bronchoscopy
Date of disclosure of the study information 2018/07/15
Last modified on 2018/06/14 08:43:17

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Basic information

Public title

Retrospective study of factors in diagnosis by means of bronchoscopy

Acronym

Retrospective study of factors in diagnosis by means of bronchoscopy

Scientific Title

Retrospective study of factors in diagnosis by means of bronchoscopy

Scientific Title:Acronym

Retrospective study of factors in diagnosis by means of bronchoscopy

Region

Japan


Condition

Condition

respiratory disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The safety and diagnostic yield of transbronchial cryobiopsy in respiratory disease

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

complications

Key secondary outcomes

procedure time, diagnostic yield


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

The patients who were performed transbronchial cryobiopsy were collected consecutively in the Japanese red cross medical center from November 2017 to May 2018.

The attending physician determined whether or not the cryobiopsy is necessary for diagnosis.

Key exclusion criteria

Patients who are not tolerable for bronchoscopy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takehiro Izumo

Organization

Japanese Red Cross Medical Center

Division name

Respiratory Medicine

Zip code


Address

4-1-22 Hiroo Shibuya-ku Tokyo 150-8935, Japan

TEL

+81-3-3400-1311

Email

drtake1118@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Naoyuki Kuse

Organization

Japanese Red Cross Medical Center

Division name

Respiratory Medicine

Zip code


Address

4-1-22 Hiroo Shibuya-ku Tokyo 150-8935, Japan

TEL

+81-3-3400-1311

Homepage URL


Email

nao-k-u@nms.ac.jp


Sponsor or person

Institute

Japanese Red Cross Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

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

日本赤十字社医療センター (東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 15 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

Completed

Date of protocol fixation

2018 Year 06 Month 05 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 06 Day

Last follow-up date

2018 Year 06 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We conducted a retrospective review from November 2017 to May 2018.


Management information

Registered date

2018 Year 06 Month 05 Day

Last modified on

2018 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037454


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name