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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025862
Receipt No. R000029722
Scientific Title A multicenter prospective study of the usefulness of endoscopic ultrasonography (EUS) in predicting the invasion depth of early gastric cancer (OGF1705)
Date of disclosure of the study information 2017/03/01
Last modified on 2017/07/29

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Basic information
Public title A multicenter prospective study of the usefulness of endoscopic ultrasonography (EUS) in predicting the invasion depth of early gastric cancer (OGF1705)
Acronym A multicenter prospective study of the usefulness of EUS in predicting the invasion depth of early gastric cancer (OGF1705)
Scientific Title A multicenter prospective study of the usefulness of endoscopic ultrasonography (EUS) in predicting the invasion depth of early gastric cancer (OGF1705)
Scientific Title:Acronym A multicenter prospective study of the usefulness of EUS in predicting the invasion depth of early gastric cancer (OGF1705)
Region
Japan

Condition
Condition Early Gastric Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of EUS for early gastric cancer diagnosed as or suspected submucosal invasive on conventional endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy by conventional endoscopy (CE) alone and the combination of CE and EUS for lesions diagnosed as CE-SM (excluding undiffernetiated cancer)
Key secondary outcomes -Diagnostic accuracy by CE alone and the combination of CE and EUS for lesions diagnosed as CE-SM (including undiffernetiated cancer)
-Diagnostic accuracy by EUS alone
-Factors of misdiagnosis by each modality

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 To perform EUS for all objectives
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) Early gastric cancer diagnosed as or suspected submucosal invasive on conventional endoscopy.
2) Age 20 or older at registration.
3) Preserved major organs functions (bone marrow, liver, kidney, lung etc.) .
4) Written informed consent from the patient himself.
Key exclusion criteria 1) Past history of gastrectomy
2) Past history of esophagectomy
3) Local recurrent lesion
4) Special types of gastric carcinoma
5) Not expected to be treated within 2 months
6) With a serious complication such as interstitial pneumonia, pulmonary fibrosis, intestinal palsy, intestinal obstruction, diabetes or hypertension difficult to control, past history of unstable angina or myocardial infarction within 6 months, liver failure, and renal failure.
7) Complicated other active cancer (but not including intraepithelial carcinoma nor intramucosal carcinoma) and when the treatment for early gastric cancer is not preferred.
8) Judged that registration or participation in this study is difficult due to a psychiatric disorder.
9) Otherwise determined by investigators to be unsuitable for participation in this study.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshito Hayashi
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Homepage URL
Email y.hayashi@gh.med.osaka-u.ac.jp

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

Funding Source
Organization Osaka University Graduate School of Medicine
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 03 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
2016 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 15 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 01 Month 26 Day
Last modified on
2017 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029722

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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