UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031291
Receipt number R000035724
Scientific Title To assess the usefulness of new EBUS-TBNA needle.
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/14 06:06:09

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Basic information

Public title

To assess the usefulness of new EBUS-TBNA needle.

Acronym

To assess the usefulness of new EBUS-TBNA needle.

Scientific Title

To assess the usefulness of new EBUS-TBNA needle.

Scientific Title:Acronym

To assess the usefulness of new EBUS-TBNA needle.

Region

Japan


Condition

Condition

Non-small cell lung cancer with advanced stage

Classification by specialty

Medicine in general Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of new EBUS-TBNA needle.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Yields of adequate tissue specimen sampling

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. Patients with enlarged mediastinal and/or hilar lesions 10 mm or greater in short-axis diameter on CT or FDG uptaken 2.5 or
higher in PET/CT imaging requiring diagnostic EBUS-TBNA
2. 20 years old and above
3. Informed consent

Key exclusion criteria

1.Patients requiring EBUS-TBNA for N-stage in patients with lung cancer
2.Serious concomitant medical illness

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyuki Nakai

Organization

National Cancer Center Hospital

Division name

Department of Endoscopy, Respiratory Endoscopy Division

Zip code


Address

5-1-1, Tukiji Chou-ku, Tokyo, Japan

TEL

03-3542-2511

Email

tnakai@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyuki Nakai

Organization

National Cancer Center Hospital

Division name

Department of Endoscopy, Respiratory Endoscopy Division

Zip code


Address

5-1-1, Tukiji Chou-ku, Tokyo, Japan

TEL

03-3542-2511

Homepage URL


Email

tnakai@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

The National Cancer Center Research and Development Fund

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 02 Month 20 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

Preinitiation

Date of protocol fixation

2018 Year 02 Month 12 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The trial does not start.


Management information

Registered date

2018 Year 02 Month 14 Day

Last modified on

2018 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035724


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name