UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062248 |
|---|---|
| Receipt number | R000071230 |
| Scientific Title | Comprehensive cancer genomic profiling before completion of standard therapy |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/15 15:55:17 |
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Basic information
Public title
Comprehensive cancer genomic profiling before completion of standard therapy
Acronym
Comprehensive cancer genomic profiling before completion of standard therapy
Scientific Title
Comprehensive cancer genomic profiling before completion of standard therapy
Scientific Title:Acronym
Comprehensive cancer genomic profiling before completion of standard therapy
Region
| Japan |
Condition
Condition
solid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to evaluate the clinical utility of performing comprehensive cancer genomic profiling (CGP) before the completion, or anticipated completion, of standard treatment in patients with advanced or recurrent solid tumors who are candidates for systemic therapy but are not eligible to undergo CGP testing under the national health insurance system before completing standard treatment because of current reimbursement requirements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
clinical utility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CGP testing using tumor tissue and or peripheral blood samples is performed in patients with solid tumors before completion of standard therapy including those expected to complete standard therapy, and the results are reviewed by an expert panel for consideration of treatment strategy.
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
1) Pathologically proven solid tumor
2) Advanced or recurrent stage eligible for systemic chemotherapy
3) The CGP test covered by insurance has not yet been performed
4) The attending physician must determine that the current CGP test is not covered by insurance at the time of study enrollment
5) Samples can be submitted suitable for genetic analysis (at least one of items 1 or 2).
1. Post-treatment residual tumor tissue sample
2. Peripheral blood samples collected specifically for this study
6) The patient consented to registering their information with the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) and using their data
7) Written consent for partcipation in this study must be obtained from the patient (for patients under 18 years of age, consent from a legal representative is required inaddition to the patient's consent). However, even if the patient understands the information provided and wishes to give consent, but is unable to sign due to neurological symptoms or other reasons, and the patient so desires, a proxy may sign on the patient's behalf to confirm consent.
Key exclusion criteria
1) Patients who have already participated in this study and have previously undergone CGP testing under the framework of Advanced Medical Care A.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sato |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Gastroenterology and Oncology
Zip code
7708503
Address
3-18-15, Kuramoto-cho, Tokushima city, 770-8503, Japan.
TEL
088-633-7124
sato.yasushi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Sato |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Gastroenterology and Oncology
Zip code
770-0934
Address
3-18-15, Kuramoto-cho, Tokushima city, 770-8503, Japan.
TEL
088-633-7124
Homepage URL
sato.yasushi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Institutional Review Board of Tokushima University
Address
3-18-15, Kuramoto-cho, Tokushima city, 770-8503, Japan.
Tel
088-615-8513
first-ec@tokushima-u.ac.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
| 2026 | Year | 07 | Month | 15 | 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
| 2026 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071230
