Unique ID issued by UMIN | UMIN000037727 |
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Receipt number | R000043026 |
Scientific Title | Real world evidence of PD-L1, TMB prevalence and efficacy of 1st line chemotherapy in these high or low population for stage IV urothelial cancer |
Date of disclosure of the study information | 2019/09/01 |
Last modified on | 2021/03/31 17:44:34 |
Real world evidence of PD-L1, TMB prevalence and efficacy of 1st line chemotherapy in these high or low population for stage IV urothelial cancer
YODO study
Real world evidence of PD-L1 prevalence and efficacy of 1st line chemotherapy for stage IV urothelial cancer
Real world evidence of PD-L1, TMB prevalence and efficacy of 1st line chemotherapy in these high or low population for stage IV urothelial cancer
YODO study
Real world evidence of PD-L1 prevalence and efficacy of 1st line chemotherapy for stage IV urothelial cancer
Japan |
Stage IV urothelial cancer
Urology |
Malignancy
YES
To evaluate prevalence of PD-L1 expression on tumor cell and immune cell in stage IV UC patients in real world setting.
Others
Secondary objectives
1.To evaluate prevalence of TMB in tissue tumor or immune cell in stage IV UC patients in real world setting.
2.To assess OS, PFS from start of 1st line treatment in stage IV.
3.To investigate treatment pattern in stage IV UC patients.
Exploratory Objective(s)
1.To evaluate cancer-immune phenotype of stage IV UC patients in real world setting.
2.To evaluate OS and PFS from start of 1st line treatment in stage IV in patients sub populations
[Sub populations]
PD-L1 high or low, negative population
PD-L1 expression on tumor tissue or immune cell; 0, 10, 25, 50, 75, 100%
TMB high or low population
Cancer-immune phenotype; Immune-desert / Immune-excluded / Inflamed
others
3.To evaluate the presence of gene mutations in primary tumor tissues in stage IV UC patients
Others
Others
Not applicable
PD-L1 High or Low/ Negative
Secondary Endpoints
1.TMB levels, TMB high or Low/ Negative
2.Median OS and OS rate at 12 months, 18 months and 24 months from start of 1st line treatment in stage IV. Median PFS and PFS rate at 6 months, 12 months and 18 months from start of 1st line treatment in stage IV.
3.Treatment patterns from 1st line treatment to 3rd line treatment in stage IV.
Exploratory Endpoints
1.Cancer immune phenotype: immune-desert, immune-excluded or inflamed
2.Median OS and OS rate at 12 months, 18 months and 24 months from start of 1st line treatment in stage IV in patients sub populations. Median PFS and PFS rate at 6 months, 12 months and 18 months from start of 1st line treatment in stage IV in patients sub populations.
[Sub populations]
PD-L1 high or low/negative population
PD-L1 expression; 0, 10, 25, 50, 75, 100%
TMB high or low population
Cancer immune phenotype; Immune-desert, immune-excluded or inflamed
3.Patients number and ratio in each gene mutations in primary tumor tissues analysed by NGS
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Age > 20, Japanese men and women.
2. Patients who have started at least 1 cycle of chemotherapy.
3.Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.
4.Patients who are diagnosed as stage IV (AJCC, 7th edition) UC between January 1st in 2017 and December 31st in 2018.
5. Patients who have FFPE primary tumor sample collected after January 1st in 2017. The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is preferable to also send a sample taken before neoajuvant therapy, even if it was taken before 1st Jan 2017.
1.Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
150
1st name | Masahisa |
Middle name | |
Last name | Jinushi |
AstraZeneca K.K.
Medical, Oncology
530-0011
Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011
06-7711-3044
Masahisa.jinushi@astrazeneca.com
1st name | Mika |
Middle name | |
Last name | Kanno |
Linical Co.,Ltd.
Contract Medical Affairs Unit, Clinical Trial Operations
105-0021
1-9-2 Higashi-shimbashi, Minato-ku, Tokyo, 105-0021, Japan
03-6215-8005
kanno-mika@linical.co.jp
AstraZeneca K.K.
AstraZeneca K.K.
Profit organization
Japan
Linical Co.,Ltd.
N/A
N/A
N/A
N/A
YES
D419BR00014
AstraZeneca K.K.
国家公務員共済組合連合会 横須賀共済病院(神奈川県)、筑波大学附属病院(茨城県)、奈良県立医科大学附属病院(奈良県)、弘前大学医学部附属病院(青森県)、浜松医科大学医学部附属病院(静岡県)、国立大学法人高知大学医学部附属病院(高知県)、独立行政法人国立病院機構 北海道がんセンター(北海道)、社会福祉法人 函館厚生院 函館五稜郭病院(北海道)、国立大学法人山口大学医学部附属病院(山口県)、地方独立行政法人神戸市民病院機構 神戸市立医療センター中央市民病院(兵庫県)、国立研究開発法人国立がん研究センター中央病院(東京都)、国立大学法人 岐阜大学医学部附属病院(岐阜県)、国立大学法人愛媛大学医学部附属病院(愛媛県)、鳥取大学医学部附属病院(鳥取県)、長崎大学病院(長崎県)、国立大学法人宮崎大学医学部附属病院(宮崎県)、大阪医科大学附属病院(大阪府)、国立大学法人東北大学東北大学病院(宮城県)、医療法人 原三信病院(福岡県)、独立行政法人労働者健康安全機構 大阪労災病院(大阪府)、公益財団法人大原記念倉敷中央医療機構 倉敷中央病院(岡山県)
2019 | Year | 09 | Month | 01 | Day |
Unpublished
Unpublished
Unpublished
143
By performing validated assay techniques on the FFPE samples, including Ventana PD-L1 (SP263) assay and NGS, PD-L1 expression, histological classification, cancer-immune phenotype, and TMB could be determined. Based on these data, prevalence of the immunogenic biomarkers including PD-L1 expression, TMB and OS, PFS from start of first-line treatment for Stage IV urothelial cancer was assessed.
2021 | Year | 03 | Month | 31 | Day |
his was a study of real-world evidence to evaluate the prevalence of PD-L1, TMB and cancer-immune phenotype as well as the correlation between these immunogenic biomarkers and clinical manifestation including prognosis and treatment regimens in 143 eligible patients with Stage IV urothelial cancer and a mean (SD) age of 71.7 (9.84) years.
Patients who provided informed consent by appropriate methods were included. In dead case or moving out case, optout was applicable according to the rule of EC.
Not applicable
Unpublished
Completed
2019 | Year | 07 | Month | 10 | Day |
2019 | Year | 09 | Month | 25 | Day |
2019 | Year | 09 | Month | 01 | Day |
2020 | Year | 03 | Month | 26 | Day |
2020 | Year | 04 | Month | 30 | Day |
2020 | Year | 10 | Month | 26 | Day |
2021 | Year | 01 | Month | 31 | Day |
Study Design
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV UC patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected from each site and conduct PD-L1 assay, classification of histology and cancer-immune phenotype and next generation sequencer (NGS) assay for TMB. Based on these data, prevalence of PD-L1 expression, TMB and OS, PFS from start of 1st line treatment in stage IV will be assessed.
In this study, 150 patients will be enrolled from 30 sites at max in Japan. The patients will be enrolled continuously from the 1st patient who is enrolled in this study until target number of patients in each site.
The patient enrolment will start from September 2019, and will end May 2020.
2019 | Year | 08 | Month | 19 | Day |
2021 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043026
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