UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022427 |
|---|---|
| Receipt number | R000025734 |
| Scientific Title | Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab |
| Date of disclosure of the study information | 2016/10/30 |
| Last modified on | 2016/05/24 11:28:35 |
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Basic information
Public title
Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Acronym
Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Scientific Title
Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Scientific Title:Acronym
Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the QOL changes by Nivolumab therapy in patients with non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
prospective observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL evaluation (FACT-L)
Key secondary outcomes
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
Stage IIIB or IV non-small cell lung cancer, Histologically or cytologically confirmed
Non-small cell lung cancer patients with treatment history
ECOG performance status must be 0-2
Acquisition of written informed consent
Key exclusion criteria
Patients without notification of their cancer disease
Patients with potential disease affecting QOL survey and handgrip test.
Those judged to be not suitable by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogawara Daiki |
Organization
Sasebo City General Hospital
Division name
Respiratory medicine
Zip code
Address
9-3 Hirase-machi, Sasebo city, Nagasaki, Japan
TEL
0956-24-1515
dogawara@hospital.sasebo.nagasaki.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ogawara Daiki |
Organization
Sasebo City General Hospital
Division name
Respiratory medicine
Zip code
Address
9-3 Hirase-machi, Sasebo city, Nagasaki, Japan
TEL
0956-24-1515
Homepage URL
dogawara@hospital.sasebo.nagasaki.jp
Sponsor or person
Institute
Sasebo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 10 | Month | 30 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
now entry
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2016 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025734
| 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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| Registered date | File name |
