UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and validation of mthods for genome and epigenome analysis of clinical samples using lung cancer tissue
Title of the study (Brief title)	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	Masafumi Muratani
Organization	Faculty of Medicine, University of Tsukuba
Division name	Genome Biology
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-7645
Email	muratani@md.tsukuba.ac.jp

Public contact
Name of contact person	Masafumi Muratani
Organization	Faculty of Medicine, University of Tsukuba
Division name	Genome Biology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018106