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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034212
Receipt No. R000039002
Scientific Title National Cancer Center Hospital (NCCH) Phase 1 Bank Study
Date of disclosure of the study information 2018/09/25
Last modified on 2019/09/21

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Basic information
Public title National Cancer Center Hospital (NCCH) Phase 1 Bank Study
Acronym NCCH Phase 1 BS
Scientific Title National Cancer Center Hospital (NCCH) Phase 1 Bank Study
Scientific Title:Acronym NCCH Phase 1 BS
Region
Japan

Condition
Condition Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Tissue banking in the patient with the advanced solid tumor who enrolled or will enroll in an early phase clinical trial.
Basic objectives2 Others
Basic objectives -Others Tissue banking in a early phase clinical trial
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Tumor and non-tumor tissue sampling based on the standardized operation procedure
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 Patient who pathologically diagnosed of cancer.
Patient who enrolled or will enroll in an early phase clinical trial.
Patient who has tissue sampling
Key exclusion criteria No definition
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Shimizu
Organization National Cancer Center Hospital
Division name Department of Experimental Therapeutics
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email tosshimi@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Koyama
Organization National Cancer Center Hospital
Division name Department of Experimental Therapeutics
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email takoyama@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 25 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 05 Day
Date of IRB
2018 Year 07 Month 12 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2028 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2018 Year 09 Month 20 Day
Last modified on
2019 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039002

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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