UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016071 |
|---|---|
| Receipt number | R000018544 |
| Scientific Title | Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis Study of evaluating SPARC expression |
| Date of disclosure of the study information | 2014/12/28 |
| Last modified on | 2023/01/04 18:59:18 |
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Basic information
Public title
Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis
Study of evaluating SPARC expression
Acronym
Study of evaluating SPARC expression in Lung Cancer with Interstitial Pneumonitis
Scientific Title
Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis
Study of evaluating SPARC expression
Scientific Title:Acronym
Study of evaluating SPARC expression in Lung Cancer with Interstitial Pneumonitis
Region
| Japan |
Condition
Condition
Advanced non-small cell carcinoma with interstitial pneumoniae
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the expression level of SPARC in the tumor cells and interstitial cells utlizing the pathological spcecimens with immunohistchemistry techniques, as the accompany research of Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis.
Basic objectives2
Others
Basic objectives -Others
see objectives 1
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the SPARC expression level of the tumor cells and interstitial cells utlizing the pathological specimens obtained from patients enrolled to the YLOG0114 study.
Key secondary outcomes
To evaluate the relationship between SPARC expression leve, other factores and treatment effectiveness.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The cases enrolled onto the YLOG0114 study whose pathological speciemens obtained at diagnosis can be suitable for immunohistchemistory evaluation.
Key exclusion criteria
The cases excepting the above.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo Medical and Dental University
Division name
Department of Respiratory Medicine
Zip code
113-8510
Address
1-5-45 Yushima Bunkyoku, Tokyo
TEL
03-5803-5954
ninase.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sakashita |
Organization
Postgraduate School of Tokyo Medical and Dental University
Division name
Division of Clinical Oncology
Zip code
113-8510
Address
1-5-45 Yushima Bunkyoku, Tokyo
TEL
03-5803-5954
Homepage URL
hsakpulm@tmd.ac.jp
Sponsor or person
Institute
Yushima Lung Cancer Oncology Group (YLOG)
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Institutes of Yushima Lung Oncology Group
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Hospital of Medicine, Clinical Research Center
Address
Tokyo Medical and Dental University Hospital of Medicine, Clinical Research Center
Tel
03-5803-5612
tiken.crc@tmd.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
英心会倉持病院、青梅市立総合病院、土浦総合病院、JA取手総合医療センター、平塚共済病院、北信総合病院、武蔵野赤十字病院、山梨県立病院、横浜市みなと赤十字病院、柏市立柏病院、九段坂病院、草加市立病院、東京共済病院、秀和病院、中野総合病院、東京医科歯科大学医学部付属病院、聖路加国際病院、多摩南部地域病院、三島社会保険病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 28 | 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
recruiting
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
| 2014 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2014 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018544
