UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008039
Receipt number R000009467
Scientific Title QOL research related to liver cysts in patients with ADPKD
Date of disclosure of the study information 2012/05/29
Last modified on 2012/05/28 12:20:38

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Basic information

Public title

QOL research related to liver cysts in patients with ADPKD

Acronym

QOL of patients with ADPKD liver cyst

Scientific Title

QOL research related to liver cysts in patients with ADPKD

Scientific Title:Acronym

QOL of patients with ADPKD liver cyst

Region

Japan


Condition

Condition

Autosomal Dominant Polycystic Kidney Disease

Classification by specialty

Hepato-biliary-pancreatic medicine Nephrology Urology
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the actual conditions of reduced QOL in ADPKD patients with huge liver cysts

Basic objectives2

Others

Basic objectives -Others

To investigate the actual conditions of reduced QOL in ADPKD patients with huge liver cysts

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

FANLTC+FACT-Hep additional concerns

Key secondary outcomes

To examine the correlation between QOL and other clinical data


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Occupying more than 25% of patients with ADPKD liver cyst

Interventions/Control_2

Occupying less than 25% of patients with ADPKD liver cyst

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

ADPKD
20 years of age or older, under the age of 80
Attending physician determines that the case is greater than or equal to 25% of hepatic cysts in the liver parenchyma by CT or MRI
Patients who get written informed consent, and meet all requirements of this test.

Key exclusion criteria

Patients with previous liver transplantation
Attending physician determines that the case can not be carried out the
evaluation of the purpose of this study (for example, can not fill out survey QOL).

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeo Horie

Organization

Teikyo University

Division name

Department of Urology

Zip code


Address

2-11-1, Kaga, Itabashi-ku

TEL

03-3964-2497

Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoru Muto

Organization

Teikyo University

Division name

Department of Urology

Zip code


Address

2-11-1, Kaga, Itabashi-ku

TEL

03-3964-2497

Homepage URL


Email

muto@med.teikyo-u.ac.jp


Sponsor or person

Institute

a Grant-in-Aid for Progressive Renal Diseases Research, from the Ministry of Health, Labour and Welfare of Japan

Institute

Department

Personal name



Funding Source

Organization

a Grant-in-Aid for Progressive Renal Diseases Research, from the Ministry of Health, Labour and Welfare of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2012 Year 05 Month 29 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

Open public recruiting

Date of protocol fixation

2012 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 05 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



Management information

Registered date

2012 Year 05 Month 28 Day

Last modified on

2012 Year 05 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009467


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name