UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004145
Receipt number R000004925
Scientific Title Frequency of mitochondrial defects in patients with chronic intestinal pseudo-ostruction in Japan.
Date of disclosure of the study information 2010/09/02
Last modified on 2010/09/02 09:20:59

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Basic information

Public title

Frequency of mitochondrial defects in patients with chronic intestinal pseudo-ostruction in Japan.

Acronym

Frequency of mitochondrial defects in patients with chronic intestinal pseudo-ostruction in Japan.

Scientific Title

Frequency of mitochondrial defects in patients with chronic intestinal pseudo-ostruction in Japan.

Scientific Title:Acronym

Frequency of mitochondrial defects in patients with chronic intestinal pseudo-ostruction in Japan.

Region

Japan


Condition

Condition

chronic intestinal pseudo-ostruction

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Chronic intestinal pseudo-ostruction(CIP) is the syndrome of unknown etiology and without an established therapy. Some CIP patients were reported to have mitochondrial defects recently, but there is no report in Japan. This study evaluates mitochondrial function in patients with CIP and make use of understanding the etiology.

Basic objectives2

Others

Basic objectives -Others

Chronic intestinal pseudo-ostruction(CIP) is the syndrome of unknown etiology and without an established therapy. Some CIP patients were reported to have mitochondrial defects recently, but there is no report in Japan. This study evaluates mitochondrial function in patients with CIP and make use of understanding the etiology.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Analysis of mitochondrial defect

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patient who are diagnosed as CIP and agreed with the study

Key exclusion criteria

patients without agreement

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name atsushi nakajima

Organization

Yokohama City University School of Medicine

Division name

Division of Gastroenterology

Zip code


Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan

TEL

0457872800

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Yokohama City University School of Medicine

Division name

Division of Gastroenterology

Zip code


Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Yokohama City University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University School of Medicine,Division of Gastroenterology

Organization

Division

Category of Funding Organization

Other

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

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 02 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

Preinitiation

Date of protocol fixation

2010 Year 09 Month 02 Day

Date of IRB


Anticipated trial start date

2010 Year 09 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

unpublished


Management information

Registered date

2010 Year 09 Month 02 Day

Last modified on

2010 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004925


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name