UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026115 |
|---|---|
| Receipt number | R000030002 |
| Scientific Title | Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with esophageal carcinoma who undergo subtotal esophagectomy |
| Date of disclosure of the study information | 2017/02/14 |
| Last modified on | 2017/02/13 16:34:48 |
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Basic information
Public title
Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with esophageal carcinoma who undergo subtotal esophagectomy
Acronym
Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with subtotal esophagectomy
Scientific Title
Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with esophageal carcinoma who undergo subtotal esophagectomy
Scientific Title:Acronym
Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with subtotal esophagectomy
Region
| Japan |
Condition
Condition
thoracic esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Chest surgery |
| Endocrine surgery | Laboratory medicine | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim the drug development of synthetic "ghrelin" as novel anti-inflammatory agent and designed the double blinded, parallelgroup study with fixed three dose regimen, randomized phase 2 study for the proof of concept and dose finding; that was "Feasibility study of synthetic ghrelin as a treatment for acute pulmonary complications of patients with esophageal carcinoma who undergo subtotal esophagectomy"
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
the level of IL-6 concentration in the blood at POD3
Key secondary outcomes
pulmonary complications, duration of SIRS (systemic inflammatory response
syndrome), the level of CRP, the level of IL-6 at POD1, 5, 7 and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
at the same time
Interventions/Control_2
at the same time
Interventions/Control_3
at the same time
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. thoracic esophageal cancer
Key exclusion criteria
1. invasion
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Doki Yuichiro |
Organization
Osaka University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyazaki Yasuhiro |
Organization
Osaka University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3251
Homepage URL
ymiyazaki@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
大阪大学医学部附属病院（大阪府）、近畿大学医学部附属病院（大阪府）、大阪府立成人病センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 13 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030002
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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