UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040743 |
|---|---|
| Receipt number | R000046492 |
| Scientific Title | Prospective study for evaluating feasibily and utility of comprehensive genomic profiling test before initial systemic treatment in advanced malignant solid tumor patients |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2023/12/25 11:11:40 |
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Basic information
Public title
Prospective study for evaluating feasibily and utility of comprehensive genomic profiling test before initial systemic treatment in advanced malignant solid tumor patients
Acronym
Upfront NCC Oncopanel Advanced medical Care
Scientific Title
Prospective study for evaluating feasibily and utility of comprehensive genomic profiling test before initial systemic treatment in advanced malignant solid tumor patients
Scientific Title:Acronym
Upfront NCC Oncopanel Advanced medical Care
Region
| Japan |
Condition
Condition
Advanced or recurrent solid cancer (non-small cell lung cancer, breast cancer, gastric cancer, colorectal cancer, pancreatic cancer, or biliary tract cancer)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the clinical utility of NCC Oncopanel test at the initiation of systemic therapy in treatment naive advanced or recurrent solid cancer (non-small cell lung cancer, breast cancer, gastric cancer, colorectal cancer, pancreatic cancer, or biliary tract cancer)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of patients treated with matched targeted therapy based on the results of NCC oncopnel test (actionable gene alterations).
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age over 16 years
2. Diagnosed with non-small cell lung cancer (EGFR/ALK/ROS-1/BRAF: negative), breast cancer (triple negative), gastric cancer, colon cancer, pancreatic cancer, and bile duct cancer.
3. Advanced disease (metastatic and/or refractory)
4. Treatment naive
5. ECOG PS 0 to 1
6. Adequate organ function
7. Tissue samples for NCC Oncopanel test
8. Registration of C-CAT
9. Written informed consent
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
nbryamam@ncc.go.jp
Public contact
Name of contact person
| 1st name | Sachie |
| Middle name | |
| Last name | Kawabata |
Organization
National Cancer Center Hospital
Division name
Project Management Section
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
NCCH1908_office@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Reserch and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sysmex CO., LTD., RIKEN GENESIS CO., LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511
irst@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
国立研究開発法人国立がん研究センター中央病院
国立研究開発法人国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046492
