UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061993 |
|---|---|
| Receipt number | R000070941 |
| Scientific Title | A Prospective Study Evaluating the Clinical Utility of Comprehensive Genomic Profiling Performed Before Completion of Standard Therapy in Patients With Advanced or Recurrent Solid Tumors |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 00:08:17 |
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Basic information
Public title
A Prospective Study Evaluating the Clinical Utility of Comprehensive Genomic Testing Before Completion of Standard Treatment in Patients With Advanced or Recurrent Cancer
Acronym
Advancing treatment decisions through Harly genomic testing in advanced cancer before standard treatment ends
Scientific Title
A Prospective Study Evaluating the Clinical Utility of Comprehensive Genomic Profiling Performed Before Completion of Standard Therapy in Patients With Advanced or Recurrent Solid Tumors
Scientific Title:Acronym
A Prospective Study Evaluating the Clinical Utility of Comprehensive Genomic Profiling Before Exhaustion of Standard Treatment in Patients With Advanced or Recurrent Solid Tumors
Region
| Japan |
Condition
Condition
Patients with advanced or recurrent solid tumors who are candidates for systemic therapy and are not eligible to undergo comprehensive genomic profiling (CGP) testing under the national insurance system before completion (or anticipated completion) of standard treatment.
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Pediatrics | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Oral surgery |
| Neurosurgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the clinical utility of performing comprehensive genomic profiling (CGP) before completion, or anticipated completion, of standard treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients who received molecularly targeted therapy for actionable genomic alterations identified by CGP testing performed in this study.
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
Prevention
Type of intervention
| Gene |
Interventions/Control_1
Japan-approved comprehensive genomic profiling (CGP) tests
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 with advanced or recurrent solid tumors who are candidates for systemic therapy.
2. No prior comprehensive genomic profiling (CGP) testing reimbursed under the national health insurance system.
3. The treating physician determines that the patient is not currently eligible for insurance-covered CGP testing under the prevailing reimbursement criteria at the time of study enrollment.
4. Availability of specimens suitable for genomic analysis, including archived tumor tissue and/or newly collected peripheral blood samples.
5. Willingness to have clinical and genomic data registered in the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) database and utilized for research purposes.
6. Provision of written informed consent by the patient prior to participation in the study.
Key exclusion criteria
Patients who have previously enrolled in this study and undergone CGP testing under the framework of Advanced Medical Care A.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kiichiro |
| Middle name | |
| Last name | Ninomiya |
Organization
Okayama University Hospital
Division name
Center for Comprehensive Genomic Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
TEL
086-235-7414
kiichiro_nino@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiichiro |
| Middle name | |
| Last name | Ninomiya |
Organization
Okayama University Hospital
Division name
Center for Comprehensive Genomic Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
TEL
0862357414
Homepage URL
kiichiro_nino@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama University Research Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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 | 06 | Month | 22 | 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 | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | 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 | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070941
