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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015583
Receipt No. R000018106
Scientific Title Development and validation of mthods for genome and epigenome analysis of clinical samples using lung cancer tissue
Date of disclosure of the study information 2014/11/01
Last modified on 2017/01/18

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Basic information
Public title Development and validation of mthods for genome and epigenome analysis of clinical samples using lung cancer tissue
Acronym Development and validation of mthods for genome and epigenome analysis of clinical samples using lung cancer tissue
Scientific Title Development and validation of mthods for genome and epigenome analysis of clinical samples using lung cancer tissue
Scientific Title:Acronym Development and validation of mthods for genome and epigenome analysis of clinical samples using lung cancer tissue
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Technical validation of genome and epigenome analysis methods developed for limited amount of samples, using clinical tissue samples.
Basic objectives2 Others
Basic objectives -Others technical validation of chromatin immunoprecipitation-sequencing protocol.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Production of chromatin immunoprecipitation data, genome variant call and information of chromatin regulation.
Key secondary outcomes Aseesment results of data quality. Accuracy of nucleotide variant call by ChIPseq data.

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 Surgically removed tissue from lung cancer cases
Key exclusion criteria Cases in which concent from patients was not obtained.
Target sample size 2

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masafumi Muratani
Organization Faculty of Medicine, University of Tsukuba
Division name Genome Biology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-7645
Email muratani@md.tsukuba.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masafumi Muratani
Organization Faculty of Medicine, University of Tsukuba
Division name Genome Biology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-7645
Homepage URL
Email muratani@md.tsukuba.ac.jp

Sponsor
Institute Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization Faculty of Medicine, University of Tsukuba
Internal funding
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 筑波大学医学医療系(茨城県)において臨床組織検体を解析

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 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
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information Analysis of lung cancer tissue samples by chroamtin immunoprecipitation-sequencing.

Management information
Registered date
2014 Year 11 Month 01 Day
Last modified on
2017 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018106

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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