UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020085
Receipt number R000023209
Scientific Title Preliminary study of the fine needle aspiration using endoscopic ultrasonography for the colorectal disease
Date of disclosure of the study information 2016/02/01
Last modified on 2021/06/10 09:14:31

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Basic information

Public title

Preliminary study of the fine needle aspiration using endoscopic ultrasonography for the colorectal disease

Acronym

Aspiration study for the colorectal disease

Scientific Title

Preliminary study of the fine needle aspiration using endoscopic ultrasonography for the colorectal disease

Scientific Title:Acronym

Aspiration study for the colorectal disease

Region

Japan


Condition

Condition

colorectal disease

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

diagnosis for the colorectal disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

diagnositic rate for the colorectal disease

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

EUS, which is approved for only upper GI diseases, is used for colorectal diseases.

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

A. 20 years old or more than 20 years old male and female
B. undiagnosed colorectal yumor

Key exclusion criteria

A. age limitations
B. allergy for rubber
C. incomplete informed consent
D. pregnant

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Masanao
Middle name
Last name Nakamura

Organization

Nagoya University Hospital

Division name

Department of Endoscopy

Zip code

466-8550

Address

65, Tsurumai-cho, Showa-ku, Nagoya

TEL

+81527442172

Email

makamura@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Masanao
Middle name
Last name Nakamura

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

466-8550

Address

65, Tsurumai-cho, Showa-ku, Nagoya

TEL

+81527442172

Homepage URL


Email

makamura@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nagoya University Graduate School of 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

Nagoya University ethic committee

Address

65, showa-ku, turumai-cho

Tel

0527442805

Email

ethic@med.nagoya-u.ac.jp


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

2016 Year 02 Month 01 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

2015 Year 12 Month 07 Day

Date of IRB

2016 Year 07 Month 07 Day

Anticipated trial start date

2016 Year 07 Month 07 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 06 Day

Last modified on

2021 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023209


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name