UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038040 |
|---|---|
| Receipt number | R000043362 |
| Scientific Title | Impact of CPFE on the clinical condition of the patients with lung cancer |
| Date of disclosure of the study information | 2019/09/20 |
| Last modified on | 2019/12/30 12:45:59 |
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Basic information
Public title
Impact of CPFE on the clinical condition of the patients with lung cancer
Acronym
Impact of CPFE on the clinical condition of the patients with lung cancer
Scientific Title
Impact of CPFE on the clinical condition of the patients with lung cancer
Scientific Title:Acronym
Impact of CPFE on the clinical condition of the patients with lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of co-existing CPFE on the clinical condition of the patients with lung cancer.
Basic objectives2
Others
Basic objectives -Others
To evaluate the influence of co-existing CPFE on the clinical condition (adverse events) of the patients with lung cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of overall survival
Key secondary outcomes
Duration of progression free survival
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pathologically confirmed lung cancer patient
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Misato |
| Middle name | |
| Last name | Okamura |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
Fushimi-Ku
TEL
0756419161
mokamup@gmail.com
Public contact
Name of contact person
| 1st name | Misato |
| Middle name | |
| Last name | Okamura |
Organization
NHO Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
Fushimi-Ku
TEL
0756419161
Homepage URL
mokamup@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
NHO Kyoto Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Kyoto Medical Center
Address
1-1, Fukakusa-Mukaihata, Fushimi-Ku, Kyoto
Tel
0756419161
mokamup@gmail.com
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
国立病院機構京都医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 20 | 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
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 30 | Day |
Other
Other related information
We will continually include patients.
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043362
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| Registered date | File name |
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