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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041008
Receipt No. R000046791
Scientific Title Elucidation of the molecular biological landscape for the development of novel therapies and diagnostics for solid tumors
Date of disclosure of the study information 2020/07/06
Last modified on 2020/07/06

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Basic information
Public title Elucidation of the molecular biological landscape for the development of novel therapies and diagnostics for solid tumors
Acronym Elucidation of the molecular biological landscape for the development of novel therapies and diagnostics for solid tumors
Scientific Title Elucidation of the molecular biological landscape for the development of novel therapies and diagnostics for solid tumors
Scientific Title:Acronym Elucidation of the molecular biological landscape for the development of novel therapies and diagnostics for solid tumors
Region
Japan

Condition
Condition Advanced Solid Malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To analyze the molecular biological profile of solid tumors using tumor tissue and blood samples, including IHC, ISH, and NGS methods, and to correlate them with pathological characteristics
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Molecular biological profiles of gene and protein expression and other genetic abnormalities in solid tumors
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 1.Usable tumor tissue samples collected between July 2011 and December 2021 are stored
2.Available blood samples collected between July 2011 and December 2021 are stored or new blood samples can be collected
3. (For National Cancer Institute cases) Blanket consent has been obtained in the National Center Biobank Network project.
Key exclusion criteria None
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name hiroya
Middle name
Last name taniguchi
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Email hirtanig@east.ncc.go.jp

Public contact
Name of contact person
1st name yoshiaki
Middle name
Last name nakamura
Organization National Cancer Center Hospital East Translational Research Management, Clinical Research
Division name Translational Research Support Section
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email yoshinak@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Cancer Center Research Ethics Review Committee
Address 5-1-1 Tsukiji, Chuo, Tokyo
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 06 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 23 Day
Date of IRB
2018 Year 12 Month 20 Day
Anticipated trial start date
2018 Year 12 Month 20 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research design: Observational study

Management information
Registered date
2020 Year 07 Month 06 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046791

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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