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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023923
Receipt No. R000027547
Scientific Title Correlation analysis of pharmacokinetic factor and cancer metastasis factor in lung cancer patients
Date of disclosure of the study information 2016/09/03
Last modified on 2018/03/15

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Basic information
Public title Correlation analysis of pharmacokinetic factor and cancer metastasis factor in lung cancer patients
Acronym Correlation analysis of pharmacokinetic factor and cancer metastasis factor in lung cancer patients
Scientific Title Correlation analysis of pharmacokinetic factor and cancer metastasis factor in lung cancer patients
Scientific Title:Acronym Correlation analysis of pharmacokinetic factor and cancer metastasis factor in lung cancer patients
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate of correlation between pharmacokinetic factor and cancer metastasis factor in lung cancer patients
Basic objectives2 Others
Basic objectives -Others The second objective of this study is to evaluate of correlation between pharmacokinetic factor, cancer metastasis factor expression and lung cancer lymph node metastasis
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of gene expression and correlation between each genes in resected tissues from lung cancer.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient who have primary lung cancer and no cancer chemotherapy in the past.
2) Patients who received removal surgery of lung cancer in Gunma Prefectural Cancer Center.
3) Patients who received sufficient explanation of this study, on a sufficient understanding, written informed consent.
Key exclusion criteria Patients who are judged as being inappropriate for this study by their medical doctor
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuo Ogihara
Organization Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Division name Laboratory of Clinical Pharmacokinetics
Zip code
Address 60 Nakaorui-machi, Takasaki-shi, Gunma
TEL 027-352-1180
Email togihara@takasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuo Ogihara
Organization Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Division name Laboratory of Clinical Pharmacokinetics
Zip code
Address 60 Nakaorui-machi, Takasaki-shi, Gunma
TEL 027-352-1180
Homepage URL
Email togihara@takasaki-u.ac.jp

Sponsor
Institute Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Gunma Prefectural Cancer Center
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 高崎健康福祉大学(群馬県)、群馬県立がんセンター(群馬県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 03 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 02 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 03 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information This study is prospective observational research which evaluate gene expression of pharmacokinetic factor and cancer metastasis factor in resected lung cancer.

We evaluate the correlation of expression level between each gene and clarify the involvement of metastasis regulators and pharmacokinetics regulators.

Management information
Registered date
2016 Year 09 Month 03 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027547

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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