UMIN-CTR Clinical Trial

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
Email	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
Email	mayamamoto@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045553