UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039950 |
|---|---|
| Receipt number | R000045553 |
| Scientific Title | PD1 gene polymorphism is associated with a poor prognosis in hepatocellular carcinoma following liver resection |
| Date of disclosure of the study information | 2020/03/26 |
| Last modified on | 2020/03/26 12:33:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
PD1 gene polymorphism is associated with a poor prognosis in hepatocellular carcinoma following liver resection
Acronym
PD1 gene polymorphism is associated with a poor prognosis in hepatocellular carcinoma following liver resection
Scientific Title
PD1 gene polymorphism is associated with a poor prognosis in hepatocellular carcinoma following liver resection
Scientific Title:Acronym
PD1 gene polymorphism is associated with a poor prognosis in hepatocellular carcinoma following liver resection
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
SNP in the promoter region of PD-1 -606 G / A has been reported to result in high activation and expression of PD-1 associated with cancer risk.
Basic objectives2
Others
Basic objectives -Others
Influence of PD-1 gene on recurrence in patients with HCC
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point is overall survival.
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
| 31 | years-old | <= |
Age-upper limit
| 91 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were as follows: the tumor was histologically diagnosed as HCC; no distant metastasis was detected in the preoperative image; hepatectomy for HCC was conducted for the first time; and absence of any other malignancies.
Key exclusion criteria
Exclusion for above statement.
Target sample size
321
Research contact person
Name of lead principal investigator
| 1st name | Masateru |
| Middle name | |
| Last name | Yamamoto |
Organization
Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Kasumi Minami-ku, Hiroshima
TEL
082-257-5555
mayamamoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masateru |
| Middle name | |
| Last name | Masateru |
Organization
Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Kasumi Minami-ku, Hiroshima
TEL
082-257-5555
Homepage URL
mayamamoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3 Kasumi, Kasumi Minami-ku, Hiroshima
Tel
082-257-5555
mayamamoto@hiroshima-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
| 2020 | Year | 03 | Month | 26 | 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
321
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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The PD-1 SNP is associated with poor survival and increased EHR in HCC. Furthermore, that is an independent predictive factor for OS and EHR.
Management information
Registered date
| 2020 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045553
