UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058128 |
|---|---|
| Receipt number | R000066380 |
| Scientific Title | QA Commons CGP |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/06/05 13:55:33 |
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Basic information
Public title
A clinical performance study to evaluate the utility of QA Commons in patients with advanced solid tumors undergoing comprehensive genomic profiling
Acronym
QA Commons CGP
Scientific Title
QA Commons CGP
Scientific Title:Acronym
QA Commons CGP
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to evaluate the clinical performance of the AI-based treatment decision support program QA Commons by assessing the concordance between its treatment recommendations and consensus annotations provided by an academic molecular tumor board in patients with advanced solid tumors who underwent comprehensive genomic profiling (CGP) in routine clinical practice.
Basic objectives2
Others
Basic objectives -Others
This study aims to evaluate the clinical performance of the AI-based treatment decision support program QA Commons by assessing the concordance between its treatment recommendations and consensus annotations provided by an academic molecular tumor board in patients with advanced solid tumors who underwent comprehensive genomic profiling (CGP) in routine clinical practice.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance between treatment recommendations by QA Commons and consensus annotations
Key secondary outcomes
Concordance between treatment recommendations by QA Commons and those made by expert panels at designated core cancer hospitals and other institutions
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. Written informed consent has been obtained for participation in the "Multicenter Clinical Registry Study by Academia Assembly", and the participant has not withdrawn or refused consent.
2. The participant was 18 years of age or older at the time of consent to the "Multicenter Clinical Registry Study by Academia Assembly".
3. The participant has undergone comprehensive genomic profiling (CGP) testing in routine clinical practice.
Key exclusion criteria
1) Required data for this study are missing.
2) The investigator deems the participant to be ineligible.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
National Cancer Center Hospital East
Division name
Division of Drug Development Promotion
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
qac01-01@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Fujisawa |
Organization
National Cancer Center Hospital East
Division name
Division of Drug Development Promotion
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
qac01-01@yokohama-cu.ac.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Genomedia Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Biostatistics, Yokohama City University
Genomedia Inc.
Name of secondary funder(s)
Japan Agency for Medical Research and Development
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo ku, Tokyo, Japan
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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Academia Assembly Registry Study (UMIN000053990)
Management information
Registered date
| 2025 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066380
