UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049415 |
|---|---|
| Receipt number | R000056264 |
| Scientific Title | The observational study of the practical application and clinical utility of cancer genomic profiling tests |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2023/09/25 10:46:15 |
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Basic information
Public title
The observational study of the practical application and clinical utility of cancer genomic profiling tests
Acronym
The observational study of the practical application and clinical utility of cancer genomic profiling tests
Scientific Title
The observational study of the practical application and clinical utility of cancer genomic profiling tests
Scientific Title:Acronym
The observational study of the practical application and clinical utility of cancer genomic profiling tests
Region
| Japan |
Condition
Condition
Advanced cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We evaluate the practical application of comprehensive genomic profiling tests covered by national insurance and assess its anti-tumor efficacy of genomically matched therapy in clinical practice. We also examine the impact of comprehensive genomic profiling tests for hereditary tumors in clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Practical application of comprehensive genomic profiling tests covered by national insurance in clinical practice
Key secondary outcomes
Anti-tumor efficacy of genomically matched therapy in clinical practice, comparison with cancer-related databases in genomic mutation (including germline variants), and functional analysis
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
Patients who undertake or consider the comprehensive profiling tests covered by the national insurance system after June 1, 2019.
Patients registered in national and international cancer-related databases will also be included in order to compare the information with treatment and genomic alterations in national and international cancer-related databases.
Key exclusion criteria
Patients who have not undergone comprehensive profiling tests covered by the national insurance system.
Target sample size
1900
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Koyama |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
takoyama@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Koyama |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
takoyama@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, 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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 02 | 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
| 2020 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following information will be collected retrospectively at any point during the study period.
Medical information (medical record number, etc.), patient background (Performance Status [PS], age, gender, cancer type, family history, etc.), specimen information (year of collection, collection method, tumor cell rate, etc.), clinical course including treatment details before and after cancer gene panel test, anti-tumor effect (Objective response The following information should be included in the data: the clinical course of the patient including the treatment before and after the cancer gene panel test, anti-tumor efficacy (objective response rate, progression-free survival, and progression-free survival ratio), results of the cancer gene panel test (whether the analysis was successful or not, breakdown of genetic abnormalities, and original genome data), and genetic studies for verification conducted when a germline pathological variant is suspected as a secondary finding. The results of genetic tests conducted for verification when a germline pathological variant is suspected as a secondary finding, the level of evidence from the "Guidance for Cancer Treatment Based on Gene Panel Tests Using Next Generation Sequencers, etc." of the Japanese Cancer Association, Japanese Association for Cancer Therapy, and Japanese Society of Clinical Oncology (the guidance of the three societies) and overseas databases (OncoKB, CIViC, etc.), the Cancer Genome Information Management Center (C-CAT), and other sources. Cancer Genome Information Management Center (C-CAT).
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056264
