UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012622 |
|---|---|
| Receipt number | R000014395 |
| Scientific Title | Additional analysis of gene polymolphisms in the phase II study of erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis (UMIN000007020) |
| Date of disclosure of the study information | 2013/12/19 |
| Last modified on | 2017/04/03 09:24:53 |
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Basic information
Public title
Additional analysis of gene polymolphisms in the phase II study of erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis (UMIN000007020)
Acronym
Additional analysis of gene polymorphisms in phase II study of erlotinib for carcinomatous meningitis
Scientific Title
Additional analysis of gene polymolphisms in the phase II study of erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis (UMIN000007020)
Scientific Title:Acronym
Additional analysis of gene polymorphisms in phase II study of erlotinib for carcinomatous meningitis
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze the relationship between gene polymorphisms associated with drug metabolize or transport and clinical response or erlotinib concentrations in plasma and CSF.
(UMIN000007020)
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene polymorphisms analysis
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
Patients enrolled onto the phase II study of erlotinib for carcinomatous meningitis who had available blood sample after 4 weeks treatment.
Key exclusion criteria
Nothing particular
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Takenoyama |
Organization
National Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
3-1-1, Notame, Minami-ku, Fukuoka, Japan, 811-1395
TEL
092-541-3231
takenoyama.m@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaname Nosaki |
Organization
National Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
3-1-1, Notame, Minami-ku, Fukuoka, Japan, 811-1395
TEL
092-541-3231
Homepage URL
nosaki.k@nk-cc.go.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Department of Clinical Pharmacology, National Cancer Center Research Institute
Akinobu Hamada
Division of Cancer Genomics,
National Cancer Center Research Institute
Tatsuhiro shibata
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
飯塚病院（福岡県）
北九州総合病院（福岡県）
九州大学（福岡県）
九州労災病院（福岡県）
久留米大学（福岡県）
国立病院機構大牟田病院（福岡県）
国立病院機構九州がんセンター（福岡県）
国立病院機構小倉医療センター（福岡県）
国立病院機構福岡東医療センター（福岡県）
国立病院機構福岡病院（福岡県）
浜の町病院（福岡県）
福岡青洲会病院（福岡県）
大分赤十字病院（大分県）
新別府病院（大分県）
JCHO諫早総合病院（長崎県）
十善会病院（長崎県）
長崎大学（長崎県）
日本赤十字社 長崎原爆病院（長崎県）
熊本地域医療センター（熊本県）
熊本赤十字病院（熊本県）
国立病院機構熊本医療センター（熊本県）
宮崎県立宮崎病院（宮崎県）
鹿児島厚生連病院（鹿児島県）
川内市医師会立市民病院（鹿児島県）
沖縄県立南部医療センター・こども医療センター（沖縄県）
国立病院機構沖縄病院（沖縄県）
国立病院機構岩国医療センター（山口県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 19 | 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 | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze retrospectively the relationship between gene polymorphisms associated with drug metabolize or transport and clinical response or erlotinib concentrations in plasma and CSF.
(UMIN000007020)
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2017 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014395
| Research Plan | |
|---|---|
| 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 |
