UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009667
Receipt number R000011340
Scientific Title prognosis of ulcerative colitis patients with reactivation of cytomegalovirus (CMV)
Date of disclosure of the study information 2012/12/30
Last modified on 2015/09/01 21:13:26

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Basic information

Public title

prognosis of ulcerative colitis patients with reactivation of cytomegalovirus (CMV)

Acronym

The reactivation of cytogegalovirus in patients with ulcerative colitis

Scientific Title

prognosis of ulcerative colitis patients with reactivation of cytomegalovirus (CMV)

Scientific Title:Acronym

The reactivation of cytogegalovirus in patients with ulcerative colitis

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

prospective cohort study of the prognosis in UC patients with reactivation of cytomeglovurus

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Remission rate in UC patients who are treataed and untreated with gancycrovir at 2 weeks after regstration of the study.

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Definitive UC patients
2 Disease Activity Index is 6-12 points
3 Either inpatients or outerpatients
4 equal or more than 16 yeras-old

Key exclusion criteria

1 patients have been entried to other clinical trial or clinical study
2 patients are planned to surgery

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Suzuki

Organization

Toho University, Medical Center, Sakura Hospital

Division name

Gastroenterology

Zip code


Address

564-1, Shimoshizu, Sakura City, Chiba prefecture

TEL

81-43-462-8811

Email

ibd.gast@sakura.med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Naganuma

Organization

Keio University, School of Medicine

Division name

Center for Diagnostic and Therapeutic Endoscopy

Zip code


Address

35 Shinanomachi, Shinjuku-KU Tokyo

TEL

81-3-3353-1211

Homepage URL


Email

cmvproject.meeting@gmail.com


Sponsor or person

Institute

Toho University, Medical Center, Sakura Hospital

Institute

Department

Personal name



Funding Source

Organization

Health and Labour Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labour and Welfare of Japan.

Organization

Division

Category of Funding Organization

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

2012 Year 12 Month 30 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

Completed

Date of protocol fixation

2012 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2014 Year 12 Month 31 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information

This study has been proceeded


Management information

Registered date

2012 Year 12 Month 30 Day

Last modified on

2015 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011340


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name