UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010417
Receipt number R000012183
Scientific Title Estimation for adequacy of histopathologic specimen based on macroscopic findings of specimen obtained by EUS-FNA using 19-gauge needle
Date of disclosure of the study information 2013/04/04
Last modified on 2015/01/17 00:55:20

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Basic information

Public title

Estimation for adequacy of histopathologic specimen based on macroscopic findings of specimen obtained by EUS-FNA using 19-gauge needle

Acronym

Estimation Study

Scientific Title

Estimation for adequacy of histopathologic specimen based on macroscopic findings of specimen obtained by EUS-FNA using 19-gauge needle

Scientific Title:Acronym

Estimation Study

Region

Japan


Condition

Condition

Solid tumor around the upper intestine

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate correlation between macroscopic findings of EUS-FNA specimen obtained a 19-gauge needle and adequacy of specimen for histopathological analysis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate correlation between macroscopic findings of EUS-FNA specimen obtained a 19-gauge needle and adequacy of specimen for histopathological analysis

Key secondary outcomes

Disagnostic power of EUS-FNA using 19-gauge needle
Safety


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 solid tumor around the upper intestine
2)performance status of 0-3
3)life expectancy more than 4 weeks
4)written informed consent obtained from the patient

Key exclusion criteria

1)severe bleeding tendency
2)severe cardiac disease, severe pulmonary disease, severe renal disease
4)pregnancy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Yasuda

Organization

Gifu University Hospital

Division name

First Dept. of Internal Medicine

Zip code


Address

1-1 Yanagido, Gifu, Gifu, Japan

TEL

058-230-6308

Email

takuji@w7.dion.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuji Iwashita

Organization

Gifu University Hospital

Division name

First Dept. of Internal Medicine

Zip code


Address

1-1 Yanagito, Gifu

TEL

058-230-6308

Homepage URL


Email

takuji-guh@umin.ac.jp


Sponsor or person

Institute

Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

岐阜大学医学部附属病院（岐阜県）Gifu University Hospital(Gifu)


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 04 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

2013 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a prospective observational study.


Management information

Registered date

2013 Year 04 Month 04 Day

Last modified on

2015 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name