UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014264
Receipt number R000016617
Scientific Title Prospective cohort study on liver disease-related tumor markers (DCP, NX-DCP, and NX-DCP-R) in patients with hepatitis C, cirrhosis, and hepatocellular carcinoma-influence by severe alcoholics
Date of disclosure of the study information 2014/06/15
Last modified on 2014/06/15 03:05:17

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Basic information

Public title

Prospective cohort study on liver disease-related tumor markers (DCP, NX-DCP, and NX-DCP-R) in patients with hepatitis C, cirrhosis, and hepatocellular carcinoma-influence by severe alcoholics

Acronym

Prospective cohort study on liver disease-related tumor markers in patients with hepatitis C, cirrhosis, and hepatocellular carcinoma-influence by severe alcoholics

Scientific Title

Prospective cohort study on liver disease-related tumor markers (DCP, NX-DCP, and NX-DCP-R) in patients with hepatitis C, cirrhosis, and hepatocellular carcinoma-influence by severe alcoholics

Scientific Title:Acronym

Prospective cohort study on liver disease-related tumor markers in patients with hepatitis C, cirrhosis, and hepatocellular carcinoma-influence by severe alcoholics

Region

Japan


Condition

Condition

Hepatitis C, cirrhosis, and hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We aim to evaluate liver fibrosis by NX-DCP in hepatitis C and cirrhotic patients. In addition, we aim to investigate specificity of NX-DCP-R in severe alcoholic patients with hepatitis C, cirrhosis, and hepatocellular carcinoma.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The evaluation of liver fibrosis by NX-DCP in hepatitis C and cirrhotic patients

Key secondary outcomes

The evaluation of specificity of NX-DCP-R in severe alcoholic patients with hepatitis C, cirrhosis, and hepatocellular carcinoma


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The determination of chronic hepatitis C was made using standard diagnostic criteria: serological detection of HCV antibodies and positive serum HCV-RNA by polymerase chain reaction for at least 6 months. All patients were na&iuml;ve to antiviral treatment.

Key exclusion criteria

We excluded patients who were taking warfarin, antibiotics, or vitamin K supplementation before laboratory measurements.

Target sample size

700


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaya Saito

Organization

Kobe University Hospital

Division name

Gastroenterology

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-5111

Email

masaya@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaya Saito

Organization

Kobe University Hospital

Division name

Gastroenterology

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-6305

Homepage URL


Email

masaya@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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

2014 Year 06 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


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

Enrolling by invitation

Date of protocol fixation

2013 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 20 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

we investigate serum NX-DCP and NX-DCP-R.


Management information

Registered date

2014 Year 06 Month 15 Day

Last modified on

2014 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016617


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name