UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038739
Receipt number R000044082
Scientific Title Utility of detective flow imaging endoscopic ultrasonography for submucosal lesions
Date of disclosure of the study information 2020/06/19
Last modified on 2023/12/01 09:24:11

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Basic information

Public title

Utility of detective flow imaging endoscopic ultrasonography for submucosal lesions

Acronym

DFI-EUS for SMT

Scientific Title

Utility of detective flow imaging endoscopic ultrasonography for submucosal lesions

Scientific Title:Acronym

DFI-EUS for SMT

Region

Japan


Condition

Condition

Submucosal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the utility of DFI-EUS for differential diagnosis in submucosal tumors.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the utility of DFI-EUS for differential diagnosis of SMTs

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

DFI-EUS and EUS were performed on the same day. Pathological diagnosis was obtained by EUS fine-needle aspiration biopsy and/or surgical specimen.

Key exclusion criteria

age < 20years

Target sample size

28


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Kitano

Organization

Wakayama Medical University

Division name

Second Department of Internal Medicine

Zip code

641-0012

Address

811-1, Kimiidera, Wakayama City, Wakayama, Japan

TEL

073-447-2300

Email

kitano@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Yasunobu
Middle name
Last name yamashita

Organization

Wakayama Medical University

Division name

Second Department of Internal Medicine

Zip code

641-0012

Address

811-1, Kimiidera, Wakayama City, Wakayama, Japan

TEL

073-447-2300

Homepage URL


Email

yasunobu@wakayama-med.ac.jp


Sponsor or person

Institute

Second Department of Internal Medicine, Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Second Department of Internal Medicine, Wakayama Medical University

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Wakayama Medical University

Address

811-1, Kimiidera, Wakayama City, Wakayama, Japan

Tel

073-447-2300/(+81)-73-4472300

Email

yasunobu@wakayama-med.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

2020 Year 06 Month 19 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 12 Month 25 Day

Date of IRB

2018 Year 12 Month 25 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2025 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To evaluate the utility of DFI-EUS for the differential diagnosis between GIST and other SMTs.


Management information

Registered date

2019 Year 11 Month 29 Day

Last modified on

2023 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044082


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name