UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048298 |
|---|---|
| Receipt number | R000054810 |
| Scientific Title | Multicenter Observational Study to Evaluate Factors Related to Angiogenesis and Tumor Immunity in Unresectable Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2023/11/21 15:16:03 |
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Basic information
Public title
Prospective Observational Study of Systemic Therapy for HCC in Japan: Exploratory Biomarker-Analysis
Acronym
PRISM-Bio Study
Scientific Title
Multicenter Observational Study to Evaluate Factors Related to Angiogenesis and Tumor Immunity in Unresectable Hepatocellular Carcinoma
Scientific Title:Acronym
PRISM-Bio Study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted to serially analyze some biomarkers of angiogenesis-related and tumor-immunity-related factors in patients treated with systemic therapy for unresectable hepatocellular carcinoma. It also aims to clarify the relationships of the biomarkers with the patient background, clinicopathological findings, treatment efficacy, and adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze some biomarkers of angiogenesis-related and tumor-immunity-related factors serially and to clarify the relationship of the biomarker with patient background, clinicopathological findings, treatment response (overall survival, progression-free survival, objective response rate, etc.), and adverse events.
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
Patients enrolled in PRISM Study with written informed consent for PRISM-Bio Study.
Key exclusion criteria
No particular setting
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Ikeda |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary & Pancreatic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
masikeda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Itoh |
Organization
Kyushu University
Division name
Department of surgery and science, Graduate school of medical science
Zip code
812-8582
Address
Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5466
Homepage URL
itoh.shinji.453@m.kyushu-u.ac.jp
Sponsor or person
Institute
Investigator Initiated Study Promotion Center
none
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.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
国立がん研究センター東病院（千葉県）、九州大学病院（福岡県）、岩手医科大学附属病院（岩手県）、千葉大学医学部附属病院（千葉県）、杏林大学医学部付属病院（東京都）、国立がん研究センター中央病院（東京都）、東邦大学医療センター大森病院（東京都）、神奈川県立がんセンター（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）、北里大学病院（神奈川県）、金沢大学附属病院（石川県）、京都府立医科大学附属病院（京都府）、大阪府立病院機構 大阪国際がんセンター（大阪府）、奈良県立医科大学附属病院（奈良県）、岡山市立市民病院（岡山県）、広島大学病院（広島県）、山口大学医学部附属病院（山口県）、愛媛県立中央病院（愛媛県）、国立病院機構 九州がんセンター（福岡県）、国立病院機構 九州医療センター（福岡県）、飯塚病院（福岡県）、熊本大学病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2022 | 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
193
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
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is possible to explore some biomarkers by correlating the information collected in PRISM Study, such as patient background, clinicopathological findings, treatment effects and adverse events, with angiogenesis-related factors and tumor immunity-related factors collected in PRISM-Bio Study.
Management information
Registered date
| 2022 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054810
