UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004218 |
|---|---|
| Receipt number | R000005069 |
| Scientific Title | Feasibility of endocytoscopy in the diagnosis of esophageal squamous-cell carcinoma : a multicenter in vivo study |
| Date of disclosure of the study information | 2010/09/21 |
| Last modified on | 2013/10/02 11:56:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility of endocytoscopy in the diagnosis of esophageal squamous-cell carcinoma : a multicenter in vivo study
Acronym
Feasibility study of ECS for esophageal squamous-cell carcinoma
Scientific Title
Feasibility of endocytoscopy in the diagnosis of esophageal squamous-cell carcinoma : a multicenter in vivo study
Scientific Title:Acronym
Feasibility study of ECS for esophageal squamous-cell carcinoma
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ECS in the diagnosis of esophageal squamous-cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity : Comparison of the ECS images and corresponding histology
Key secondary outcomes
1) multi-rator k value in the pathologists
2) the proportion of high quality ECS images sufficient to evaluation
3) Specificity
4) multi-rator k value between the pathologists and endoscopists
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) superficial esophageal cancer larger than 10 mm in size and histologically confirmed as squamous-cell carcinoma or high grade intraepithelial neoplasia
2) Written informed consent
Key exclusion criteria
1) severe complication
2) having prior radiotherapy for the esophagus
3) having prior chemotherapy
4) contraindication for biopsy and endoscopic treatment
5) inadequate to entry considered by each investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507
TEL
075-751-4319
shuko@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuko Morita |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507
TEL
075-751-4319
Homepage URL
shuko@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation For Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
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 | 09 | Month | 21 | 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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 07 | Month | 22 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2010 | Year | 09 | Month | 15 | Day |
Last modified on
| 2013 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005069
