UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015583
Receipt number 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 13:28:35

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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

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

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 or person

Institute

Faculty of Medicine, University of Tsukuba

Institute

Department

Personal name



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

Value
https://center6.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