UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017562 |
|---|---|
| Receipt number | R000017780 |
| Scientific Title | Evaluation of 18F-FDG uptake for detecting lymph node metastasis of esophagus cancer |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2016/10/25 01:43:37 |
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Basic information
Public title
Evaluation of 18F-FDG uptake for detecting lymph node metastasis of esophagus cancer
Acronym
Evaluation of 18F-FDG uptake for detecting lymph node metastasis of esophagus cancer
Scientific Title
Evaluation of 18F-FDG uptake for detecting lymph node metastasis of esophagus cancer
Scientific Title:Acronym
Evaluation of 18F-FDG uptake for detecting lymph node metastasis of esophagus cancer
Region
| Japan |
Condition
Condition
Esophagus cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between 18F-FDG uptake and the presence/absence of metastasis in individual lymph nodes on a one-to-one basis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between 18F-FDG uptake and lymph node involvement
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
(1) Squamous cell carcinoma of esophagus confirmed by pathological examination
(2) Enable to proceed curative operation
(3) normal heart, renal,and liver function
(4) European clinical oncology group performance status (ECOG PS) 0 or 1
(5)Enable to examine PET-CT
Key exclusion criteria
(1) severe drug allergy
(2) diabetes mellitus
(3) any severe ongoing comorbidity
(4) prior malignant diseases
(5) synchronous malignant diseases other than gastric cancer
(6) contraindication of FDG PET including pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto |
Organization
University of Tokyo Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto |
Organization
University of Tokyo Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
Homepage URL
seto-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
operating cost of Department of Gastrointestinal surgery
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
| 2015 | Year | 05 | Month | 14 | 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
| 2014 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2016 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017780
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