UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041008 |
|---|---|
| Receipt number | 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 | 2025/12/11 15:45:54 |
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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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients over 18 years of age with histologically diagnosed malignancy
2. Usable tumor tissue samples collected between July 2011 and December 2021 are stored
3. Available blood samples collected between July 2011 and December 2021 are stored or new blood samples can be collected
4. (For National Cancer Institute cases) Blanket consent has been obtained in the National Center Biobank Network project.
5. Molecular profiling tests (gene panel tests, immunohistochemistry, etc.) are performed at the National Cancer Center Hospital East under the insurance reimbursement.
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
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
yoshinak@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Fujisawa |
Organization
Department of the Promotion of Drug and Diagnostic Development, National Cancer Center Hospital East
Division name
Translational Research Support Office, Division of Drug and Diagnostic Development Promotion
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
tafujisa@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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)
Guardant Health Inc., National Cancer Center Hospital East
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
5-1-1 Tsukiji, Chuo, Tokyo
Tel
03-3542-2511
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
九州大学(福岡県)、宗像医師会病院(福岡県)、Guardant Health Inc.（USA）
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
| 2026 | 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
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046791
