UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004880 |
|---|---|
| Receipt number | R000005810 |
| Scientific Title | Clinical Research; Efficacy of human atrial natriuretic peptide (hANP) on lung cancer surgery Basic Research; Efficacy of hANP on lung cancer |
| Date of disclosure of the study information | 2011/05/18 |
| Last modified on | 2015/04/28 16:19:00 |
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Basic information
Public title
Clinical Research; Efficacy of human atrial natriuretic peptide (hANP) on lung cancer surgery
Basic Research; Efficacy of hANP on lung cancer
Acronym
hANP study of lung cancer
Scientific Title
Clinical Research; Efficacy of human atrial natriuretic peptide (hANP) on lung cancer surgery
Basic Research; Efficacy of hANP on lung cancer
Scientific Title:Acronym
hANP study of lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of hANP on lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
1.The early reccurence of lung cancer after pulmonary resection
2.The incidence of postoperative complications after lung cancer surgery
Key secondary outcomes
1.Postoperative hemodynamics
2.Postoperative inflammatory change (white blood cell count and C-reactive protein level)
3.Postoperative creatinine levels and glomerular filtration rate
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group of hANP treatment
Interventions/Control_2
Control group
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients undergoing pulmonary resection for lung cancer in our hospital
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
Osaka University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
Address
2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan
TEL
06-6879-3152
nojiri@ri.ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
National Cerebral and Cardiovascular Center
Division name
Biochemistry
Zip code
Address
5-7-1, Fujishirodai, Suita-City, Osaka 565-8565
TEL
06-6833-5012
Homepage URL
nojiri@ri.ncvc.go.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
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
National Cerebral and Cardiovascular Center
National Toneyama Hospital
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
大阪大学附属病院（大阪府）
国立循環器病研究センター（大阪府）
国立病院機構刀根山病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 18 | 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
Completed
Date of protocol fixation
| 2006 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 14 | Day |
Last modified on
| 2015 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005810
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
