UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035341 |
|---|---|
| Receipt number | R000040260 |
| Scientific Title | Cardiopulmonary exercise test for high risk lung cancer surgery |
| Date of disclosure of the study information | 2018/12/21 |
| Last modified on | 2020/12/22 17:01:10 |
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Basic information
Public title
Cardiopulmonary exercise test for high risk lung cancer surgery
Acronym
Cardiopulmonary exercise test for high risk lung cancer surgery
Scientific Title
Cardiopulmonary exercise test for high risk lung cancer surgery
Scientific Title:Acronym
Cardiopulmonary exercise test for high risk lung cancer surgery
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the efficacy of cardiopulmonary exercise test for high risk lung cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relationship between CPET and perioperative complications
Key secondary outcomes
relationship between CPET and six minute walk test, respiratory function test and echocardiogram
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
ergometer
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 Lung cancer
2 Pneumonectomy
3 ppo%FEV1<60% or ppo%DLCO<60%
Key exclusion criteria
1 Not appropriate for CPET
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagayasu |
Organization
Nagasaki University Graduate School of Medicine
Division name
Surgical Oncology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7304
nagayasu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Miyazaki |
Organization
Nagasaki University Graduate School of Medicine
Division name
Surgical Oncology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7304
Homepage URL
miyataku@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Medicine
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
Nagasaki University Graduate School of Medicine
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
Tel
095-819-7304
miyataku@nagasaki-u.ac.jp
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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
10
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
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 21 | Day |
Last modified on
| 2020 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040260
