UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018617 |
|---|---|
| Receipt number | R000020838 |
| Scientific Title | Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2016/10/03 18:41:36 |
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Basic information
Public title
Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Acronym
Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Scientific Title
Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Scientific Title:Acronym
Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the difference of post-operative complication and survival between single primary cancer and multiple primary cancer. Also, clarify the risk factor of operation in multiple primary cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
post-operative complication, overall survival rate, esophageal cancer specific survival rate
Key secondary outcomes
operation time, reconstruction method, blood loss, operation related death, treatment of other primary cancer, histology type, TNM classification
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. Patients who were diagnosed as esophageal cancer
2. age; over 20 years old and under 85 years old
3. Patients without recurrence of antecedent cancers.
Key exclusion criteria
Whenever the patients or the bereaved families rejected to use the data for the clinical study
Target sample size
294
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kakeji |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastrointesitnal
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe city
TEL
078-382-5925
kakeji@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Nakamura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastrointesitnal Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe city
TEL
078-382-5925
Homepage URL
tetsun@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Gastrointesitnal Surgery
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine, Division of Gastrointesitnal 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 | 09 | Month | 01 | 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
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective, case control study
Management information
Registered date
| 2015 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020838
