UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050577 |
|---|---|
| Receipt number | R000057187 |
| Scientific Title | Practical research with comprehensive cancer genome profiling under the purpose to develop precision medicine system for patients with cancer |
| Date of disclosure of the study information | 2023/03/14 |
| Last modified on | 2024/04/02 13:42:00 |
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Basic information
Public title
Preclinical research with cancer genome profiling, FoundationOne CDx
Acronym
Practical research with CGP, F1CDx
Scientific Title
Practical research with comprehensive cancer genome profiling under the purpose to develop precision medicine system for patients with cancer
Scientific Title:Acronym
Preclinical research with comprehensive CGP
Region
| Japan |
Condition
Condition
Solid tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology | Hematology and clinical oncology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Breast surgery | Dermatology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We aim (1) development of the operation process in Japan of the comprehensive cancer-related gene analysis system F1CDx (sequence success rate), (2) analysis of tumor gene mutation (Frequency of detection of actionable gene alternations), and (3) preclinical and retrospective research on the relationship between gene mutation and treatment (administration rate of corresponding therapeutic drug, concordance rate with approved diagnostic examinations, overall survival) as endpoints.
Basic objectives2
Others
Basic objectives -Others
Our final purpose is the precision oncology for patients with solid tumor.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of detection of actionable genetic alternations
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with malignant solid tumor pathologically from January 1, 2015
(2) Patients with high-grade tumors requiring perioperative chemotherapy or with unresectable or recurrent lesions
(3) Patients who fully understand this research plan and can give their consent
(4) Patients aged 20 years or older at the time of informed consent
Key exclusion criteria
Patients judged by researchers to be uneligible as research subjects
Target sample size
205
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City, 812-8582, Japan
TEL
092-642-5440
Kubo.makoto.804@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City, 812-8582, Japan
TEL
092-642-5440
Homepage URL
Kubo.makoto.804@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chugai Pharmaceutical Co.,Ltd.
Foundation Medicine Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Ethical Review Committe
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City, Japan
Tel
092-642-6254
ijkseimei@jimu.kyushu-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
| 2023 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
212
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
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2023 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057187
