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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name