UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005718
Receipt number R000006759
Scientific Title Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis
Date of disclosure of the study information 2011/06/06
Last modified on 2016/02/11 10:35:54

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Basic information

Public title

Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis

Acronym

Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis

Scientific Title

Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis

Scientific Title:Acronym

Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis

Basic objectives2

Others

Basic objectives -Others

Clinical significance of measurement of CXCR4 expression on CD4 positive T cell as a predictive marker on the effect of leukocytapheresis

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

CXCR4 expression on CD4 positive T cell in peripheral blood

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Patients treated with leukocytapheresis (more than once per week, total 10 sessions) therapy have a regular blood test

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

12 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with moderate, severe or intractable ulcerative colitis
2) Patients with ulcerative colitis of left side colitis or pancolitis type
3) Patients whom immunomodulator doses are not changed for two months
4) Patients that steroid doses are not increased in quantity for one week

Key exclusion criteria

1) Patients with proctitis
2) Patients with either white blood cell count of less than 3,000/mm3, or hemoglobin level of less than 10g/dL, or platelet count of less than 100,000/mm3
3) Patients with fulminating active ulcerative colitis (massive bleeding, perforation, toxic megacolon)
4) Patients with serious infection or cardiovascular disease or liver disease or kidney disease or respiratory disease or metabolic disease neurologic disease
5) Patients with hypotension (less than maximal blood pressure 80mmHg)
6) Patients with allergic anamnesis or experience or the fear of allergic hypersensitivity reaction
7) Patients having received inhibitor of angiotensin converting enzyme
8) Patients who are pregnant or have the possibility of pregnancy
9) Patients who are younger than 12 years old or low weight
10) Patients determined to be inappropriate for this study by the investigators

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Nakase

Organization

Kyoto University Hospital

Division name

Division of Endoscopic Medicine

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

TEL

075-751-4319

Email

hiropy_n@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Minoru Matsuura

Organization

Kyoto University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

TEL

075-751-4319

Homepage URL


Email

minomats@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto 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

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 06 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

2011 Year 05 Month 02 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2013 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 06 Month 03 Day

Last modified on

2016 Year 02 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006759


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name