UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000026246
Receipt number	R000030140
Scientific Title	Identification of the actual states of the occurrence of hepatocellular carcinoma in patients with type 2 diabetes.
Date of disclosure of the study information	2017/02/21
Last modified on	2017/02/25 13:33:14

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Basic information

Public title

Identification of the actual states of the occurrence of hepatocellular carcinoma in patients with type 2 diabetes.

Acronym

the occurrence of hepatocellular carcinoma in type 2 diabetic patients.

Scientific Title

Identification of the actual states of the occurrence of hepatocellular carcinoma in patients with type 2 diabetes.

Scientific Title:Acronym

the occurrence of hepatocellular carcinoma in type 2 diabetic patients.

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Hepato-biliary-pancreatic medicine Endocrinology and Metabolism

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The aim of the present study is to establish the high risk group on the occurrence of hepatocellular carcinoma in type 2 diabetes.

Basic objectives2

Others

Basic objectives -Others

observational study

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Comparison of several data showed below between HCC-developed and HCC-undeveloped type 2 diabetic patients.
1) gender, age, BMI, abdominal circumference, maximum body weight, treatment of diabetes, hypertension and dislipidemia, history of alcohol
2) blood examination: number of Plates
3) Blood chemistry: Albumin, AST, ALT, T-bil, BUN, s-Cre, GGT, ALP, T-Chol, TG, HDL-C, UA, blood glucose level, HbA1c, glicoalbumin
4) coagulation: prothrombin time

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects with type 2 diabetes who has non-B or non-C hepatocellular cancer and were followed by specialists of diabetes for at least 5 years were enrolled in this study. Moreover, subjects with diabetes who were enrolled in the "Okanoue study designed from Ministry of Health, Labour and Welfare: The observational study of NASH for the clarification of clinical states, diagnostic procedure and novel therapeutics."

Key exclusion criteria

1) Subjects who were diagnosed as hepatocellular carcinoma at the age of 25 or less.
2) Subjects who were diagnosed as chronic hepatitis B or chronic hepatitis C.
3) Subjects who were not sutbable to enroll the study by physician in charge.

Target sample size

600

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Eiichi Araki

Organization

Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University

Division name

Department of Metabolic Medicine

Zip code

Address

1-1-1 Honjo, Chuo, Kumamoto, Kumamoto, 860-8556, Japan

TEL

0963735169

Email

earaki@gpo.kumamoto-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Takeshi Matsumura

Organization

Kumamoto University Hospital

Division name

Diabetes, Metabolism and Endocrinology

Zip code

Address

1-1-1 Honjo, Chuo, Kumamoto, Kumamoto, 860-8556, Japan

TEL

0963735169

Homepage URL

Email

takeshim@gpo.kumamoto-u.ac.jp

Sponsor or person

Institute

Kumamoto University

Institute

Department

Personal name

Funding Source

Organization

Japan Agency for Medical Research and Development: AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Department of Gastroenterology, The University of Tokyo Hospital
Department of Diabetes and Metabolic Diseases, The University of Tokyo Hospital

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 21 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

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

Date of protocol fixation

2016 Year 10 Month 25 Day

Date of IRB

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

We are now recruiting subjects with type 2 diabetes who has non-B or non-C hepatocellular cancer and were followed by specialists of diabetes for at least 5 years.

Management information

Registered date

2017 Year 02 Month 21 Day

Last modified on

2017 Year 02 Month 25 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030140

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name