UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025862 |
|---|---|
| Receipt number | 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 | 2023/01/31 20:31:54 |
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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 | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
Homepage URL
y.hayashi@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
Osaka University Clinical Research Review Committee
Address
2-15 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2017 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36536083/
Number of participants that the trial has enrolled
180
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
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2022 | 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
| 2017 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029722
