UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002047 |
|---|---|
| Receipt number | R000002492 |
| Scientific Title | A phase II trial of endoscopic submucosal dissection (ESD) for superficial esophageal cancer (KDOG 0901) |
| Date of disclosure of the study information | 2009/06/04 |
| Last modified on | 2015/04/29 21:14:36 |
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Basic information
Public title
A phase II trial of endoscopic submucosal dissection (ESD) for superficial esophageal cancer (KDOG 0901)
Acronym
A phase II trial of ESD for superficial esophageal cancer (KDOG 0901)
Scientific Title
A phase II trial of endoscopic submucosal dissection (ESD) for superficial esophageal cancer (KDOG 0901)
Scientific Title:Acronym
A phase II trial of ESD for superficial esophageal cancer (KDOG 0901)
Region
| Japan |
Condition
Condition
Superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD)for superficial esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete en bloc resection rate
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic Submucosal Dissection (ESD)
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
Patients with superficial esophageal cancer who agreed with written informed consent
Key exclusion criteria
1. Active synchronous or metachronous malignancy
2. Severe concomitant disease
3. Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine, Department of Gastroenterology
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
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
| 2009 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2009 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 04 | Day |
Last modified on
| 2015 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002492
