Unique ID issued by UMIN | UMIN000033647 |
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Receipt number | R000038129 |
Scientific Title | Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors |
Date of disclosure of the study information | 2018/08/10 |
Last modified on | 2023/08/10 09:27:44 |
Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors
Todai OncoPanel (Advanced Medical Care Category B)
Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors
Todai OncoPanel (Advanced Medical Care Category B)
Japan |
Malignant solid tumors (including both carcinoma and sarcoma)
Hematology and clinical oncology |
Malignancy
YES
To estimate usefulness of a multiplex genomic testing "Todai OncoPanel"
Safety,Efficacy
Ratio of actionable genomic alterations (both therapeutically and diagnostically)
Observational
Not applicable |
Not applicable |
Male and Female
1) Pathologically diagnosed as malignant tumors (either carcinoma or sarcoma) (except for hematopoietic malingancies)
2) Considered to be incurable due to unresectable or recurrent condition
3) Already treated by standard therapies
4) Genomic testing is considered to be useful for decision of a therapeutic option
5) Performance Status: 0 or 1
6) Tumor sample is sufficiently available for the testing
7) Written informed consent
None
200
1st name | Katsutoshi |
Middle name | |
Last name | Oda |
The University of Tokyo Hospital
Department of Obstetrics and Gynecology
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
katsutoshi-tky@umin.ac.jp
1st name | Shiori |
Middle name | |
Last name | Toyomaru |
The University of Tokyo Hospital
Medical Research Division
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
http://todaioncopanel.umin.jp/
rinsho@adm.h.u-tokyo.ac.jp
The University of Tokyo Hospital
Japan Agency for Medical Reserch and Development
Government offices of other countries
Sysmex CO., LTD., RIKEN GENESIS CO., LTD., Xcoo CO.LTD.
Graduate School and Faculty of Medicine, The University of Tokyo
7-3-1 Hongo, Bunkyoo-ku, Tokyo
03-3815-5411
ethics@m.u-tokyo.ac.jp
NO
2018 | Year | 08 | Month | 10 | Day |
doi: 10.1111/cas.15717.
Published
doi: 10.1111/cas.15717.
200
One hundred and four samples (53%) harbored gene alterations that were detected with the DNA panel and had potential treatment implications, and 14 samples (7%) had a high tumor mutational burden. Thirteen patients (7%) were found to have pathogenic or likely pathogenic germline variants and genetic counseling was recommended. Overall, 12 patients (6%) received recommended treatment.
2023 | Year | 08 | Month | 10 | Day |
2023 | Year | 01 | Month | 17 | Day |
Patients with cancers without standard treatment or when patients had already undergone standard treatment.
Todai OncoPanel (TOP) is a dual DNA-RNA panel as well as a paired tumor-normal matched test. Two hundred patients underwent TOP as part of Advanced Medical Care B with approval from the Ministry of Health, Labour and Welfare between September 2018 and December 2019.
N/A
Primary endpoint: ratio of patients who harbored 1) and/or 2) findings by Todai OncoPanel.
1) one or more alterations with Tier 1, 2 and R, and/or hypermutator (Tumor Mutational Burden-High)
2) supportive for pathological diagnosis
The ratio was 59.1%.
Completed
2018 | Year | 07 | Month | 05 | Day |
2018 | Year | 07 | Month | 03 | Day |
2018 | Year | 08 | Month | 29 | Day |
2020 | Year | 01 | Month | 31 | Day |
2023 | Year | 08 | Month | 10 | Day |
Estimated Registration Completion Date: Dec 31, 2019
2018 | Year | 08 | Month | 06 | Day |
2023 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038129
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