UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025697 |
|---|---|
| Receipt number | R000029546 |
| Scientific Title | Outcome analysis after endoscopic resection of esophageal cancer invading into muscularis mucosa or upper part of submucosa. |
| Date of disclosure of the study information | 2017/01/17 |
| Last modified on | 2022/07/22 13:19:59 |
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Basic information
Public title
Outcome analysis after endoscopic resection of esophageal cancer invading into muscularis mucosa or upper part of submucosa.
Acronym
Outcome analysis after endoscopic resection of esophageal cancer
Scientific Title
Outcome analysis after endoscopic resection of esophageal cancer invading into muscularis mucosa or upper part of submucosa.
Scientific Title:Acronym
Outcome analysis after endoscopic resection of esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of endoscopic resection for esophageal cancer invading into MM/SM1 on histologic examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically diagnosed MM/SM1 esophageal cancer on endoscopically resected specimen.
Key exclusion criteria
1 Clinically confirmed metastasis.
2 Cancers treated with piecemeal resection
3 Incomplete removal of cancer by endoscopic resection
4 Positive or indifinite for vertical margin
5 Recurrence after endoscopic resection
6 Previous radiation to mediastinum
7 Non curative cancer in other organs
8 Past history of esophagectomy or gastrectomy
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Tsuneo |
| Middle name | |
| Last name | Oyama |
Organization
Saku Central Hospital Advanced care center
Division name
Department of Endoscopy
Zip code
385-0051
Address
3400-28, Nakagome, Saku city, Nagano, Japan
TEL
0267-62-8181
oyama@coral.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka city, Osaka, Japan
TEL
06-6972-1181
Homepage URL
isihara-ry@mc.pref.osaka.jp
Sponsor or person
Institute
Saku Central Hospital Advanced care center
Institute
Department
Personal name
Funding Source
Organization
Self-financed
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
Saku Central Hospital Advanced care center
Address
3400-28, Nakagome, Saku city, Nagano, Japan
Tel
0267-62-8181
isihara-ry@mc.pref.osaka.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
恵佑会第2病院
東北大学
国立がん研究センター中央病院
がん研有明病院
虎ノ門病院
国立がん研究センター東病院
佐久医療センター
静岡がんセンター
大阪府立成人病センター
兵庫県立がんセンター
岡山大学
福岡大学筑紫病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 17 | 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
Date of protocol fixation
| 2017 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 01 | Month | 16 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029546
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
