UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028059
Receipt No. R000031941
Scientific Title Usefulness of forward-viewing radial-array endoscopic ultrasonography for evaluating invasion depth of colorectal neoplasms
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Usefulness of forward-viewing radial-array endoscopic ultrasonography for evaluating invasion depth of colorectal neoplasms
Acronym Usefulness of forward-viewing radial-array endoscopic ultrasonography for evaluating invasion depth of colorectal neoplasms
Scientific Title Usefulness of forward-viewing radial-array endoscopic ultrasonography for evaluating invasion depth of colorectal neoplasms
Scientific Title:Acronym Usefulness of forward-viewing radial-array endoscopic ultrasonography for evaluating invasion depth of colorectal neoplasms
Region
Japan

Condition
Condition colorectal neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of forward-viewing radial-array endoscopic ultrasonography for evaluating invasion depth of colorectal neoplasms
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The accuracy for invasion depth of colorectal neoplasms
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We diagnose the invasion depth by pit pattern and EUS in the same group.
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 #Patients who are over 20 years old when the patients consent
#Patients who are with neoplasms
#Patients who will be treated by endoscopy or surgery
#Patients who consent with the document
Key exclusion criteria #Patients who are judged as inappropriate by investigator
#Patients who are without the self judgement abilities
#Patients who are with the history of chemotherapy(including endcrine therapy) and radiation therapy
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Yamamura
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65 Tsurumaichou,Shouwa-ku, Nagoya 466-8560,Japan
TEL 052-741-2172
Email tyamamu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kuno
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 Tsurumaichou,Shouwa-ku, Nagoya 466-8560,Japan
TEL 052-741-2172
Homepage URL
Email tkuno@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2017 Year 10 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 03 Day
Last modified on
2017 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.