UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011018 |
|---|---|
| Receipt number | R000012900 |
| Scientific Title | Prognostic impact of MPV for non–squamous non–small cell lung cancer patients who received front line chemotherapy in combination with bevacizumab: A retrospective analysis. |
| Date of disclosure of the study information | 2013/06/24 |
| Last modified on | 2021/07/02 09:57:52 |
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Basic information
Public title
Prognostic impact of MPV for non–squamous non–small cell lung cancer patients who received front line chemotherapy in combination with bevacizumab: A retrospective analysis.
Acronym
MPV and Bevacitumab in NSCLC.
Scientific Title
Prognostic impact of MPV for non–squamous non–small cell lung cancer patients who received front line chemotherapy in combination with bevacizumab: A retrospective analysis.
Scientific Title:Acronym
MPV and Bevacitumab in NSCLC.
Region
| Japan |
Condition
Condition
non–squamous non–small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate Biological effects of Bevacizumab to MPV.
Basic objectives2
Others
Basic objectives -Others
Survival impact of MPV
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Biological effects of bevacizumab to MPV.
Key secondary outcomes
Contribution of MPV for survival of NSCLC patients who received chemotherapy in combination with Bevacizumab.
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
Histologicaly or cytologicaly diagnosed non-squamous NSCLC.
Stage IV (7th edition) at initial diagnosis.
Patients of non squamous NSCLC who received front line chemotherapy at Hirakata or Kansai Medical University Takii Hospital from November 2009 to April 2012.
Key exclusion criteria
Patients who lack adequate medical record.
Patients who received thoracic irradiation with curative intention.
Patients who were diagnosed as LC-NEC.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
1st department of internal medicine
Zip code
Address
Shin-machi 2-3-1, Hirakata-city, Osaka.
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
1st department of internal medicine
Zip code
Address
Shin-machi 2-3-1, Hirakata-city, Osaka.
TEL
072-804-0101
Homepage URL
nomurash@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
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
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
関西医科大学附属枚方病院（大阪府）Kansai Medical University Hirakata Hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 24 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
To evaluate the efficacy of MPV as a predictive factor for OS of NSCLC patients who received front line chemotherapy in combination with Bevacizumab.
Management information
Registered date
| 2013 | Year | 06 | Month | 22 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012900
