UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007336 |
|---|---|
| Receipt number | R000008644 |
| Scientific Title | A prospective study between OCT and EUS for tumor staging of superficial esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2012/02/22 |
| Last modified on | 2012/02/20 14:48:09 |
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Basic information
Public title
A prospective study between OCT and EUS for tumor staging of superficial esophageal squamous cell carcinoma
Acronym
A prospective study between OCT and EUS for tumor staging of superficial esophageal squamous cell carcinoma
Scientific Title
A prospective study between OCT and EUS for tumor staging of superficial esophageal squamous cell carcinoma
Scientific Title:Acronym
A prospective study between OCT and EUS for tumor staging of superficial esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
esophageal superficial squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of OCT for tumor staging of esophageal squamous cell carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
accuracy of tumor staging of esophageal squamous cell carcinoma
Key secondary outcomes
safety of the staging process
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
the preoperative assessment of tumor staging of esophageal squamous cell carcinoma by EUS
Interventions/Control_2
the preoperative assessment of tumor staging of esophageal squamous cell carcinoma by OCT
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with superficial esophageal squamous cell carcinoma diagnosed by endoscopic examination and confirmed by resected specimens
Key exclusion criteria
having any precious treatment for esophageal diseases, having no specimen sufficient for a definite histological staging, having been examined by either EUS or OCT
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tooru Shimosegwa |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi Japan
TEL
022-717-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaname Uno |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
TEL
Homepage URL
kaname@wa2.so-net.ne.jp
Sponsor or person
Institute
Tohoku University, Graduate School of Medicine, Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Profit organization
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 20 | Day |
Last modified on
| 2012 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008644
