UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003766 |
|---|---|
| Receipt number | R000004561 |
| Scientific Title | Magnifyin endoscopy with narrow band imaging versus endoscopic ultrasonography for predicting the invasion depth of superficial esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2010/06/16 |
| Last modified on | 2010/12/20 08:39:09 |
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Basic information
Public title
Magnifyin endoscopy with narrow band imaging versus endoscopic ultrasonography for predicting the invasion depth of superficial esophageal squamous cell carcinoma
Acronym
NBI vs EUS for predicting the invasion depth of esophageal carcinoma
Scientific Title
Magnifyin endoscopy with narrow band imaging versus endoscopic ultrasonography for predicting the invasion depth of superficial esophageal squamous cell carcinoma
Scientific Title:Acronym
NBI vs EUS for predicting the invasion depth of esophageal carcinoma
Region
| Japan |
Condition
Condition
Patients with superficial squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic accuracy of the invaion depth of superficial squamous cell carcinoma of the esophagus between EUS and NBI with magnifying endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis of invaion depth of superficial squamous cell carcinoma of the esophagus by EUS and NBI with magnifying endoscopy
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To evaluate the invasion depth of superficial squamous cell carcinoma by EUS and NBI with magnifying endoscopy from Jun 2010 through Jun 2012.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed squamous cell carcinoma.
2. Patients with superficial esophageal carcinoma
3. Patients without major organ failure.
4. A written informed concent is obtained.
5. Patients scheduled to underwent endoscopic resection or surgery.
Key exclusion criteria
1. Hemorrhagic diseases
2. Patients with other advanced cancer
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ishihara Ryu |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastrointestinal Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinariku, Osaka 537-8511 Japan
TEL
06-6972-1181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hanaoka Noboru |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastrointestinal Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 06 | Month | 16 | 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
| 2010 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | 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
| 2010 | Year | 06 | Month | 16 | Day |
Last modified on
| 2010 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004561
