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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045553


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name