UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009453
Receipt number R000011107
Scientific Title Study of pathomechanism, prediction and bio-marker for severe cutaneous adverse reaction
Date of disclosure of the study information 2012/12/01
Last modified on 2013/12/17 14:32:21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study of pathomechanism, prediction and bio-marker for severe cutaneous adverse reaction

Acronym

Study of pathomechanism, prediction and bio-marker for severe cutaneous adverse reaction

Scientific Title

Study of pathomechanism, prediction and bio-marker for severe cutaneous adverse reaction

Scientific Title:Acronym

Study of pathomechanism, prediction and bio-marker for severe cutaneous adverse reaction

Region

Japan


Condition

Condition

severe cutaneous adverse reaction

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to elucidate pathomechanism, prediction, and bio-marker for severe cutaneous adverse reaction

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of bio-marker for severe cutaneous adverse reaction

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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Collection of 5ml peripheral blood and 2 pieces of skin biopsies

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Severe cutaneous adverse reaction patient who agreed informed consent

Key exclusion criteria

patient who is recognized as inadequate for joining this study by principal investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Azukizawa

Organization

Osaka University, Graduate School of Medicine

Division name

Department of Dermatology

Zip code


Address

2-2, Yamadaoka, Suita, 565-0871 JAPAN

TEL

06-6879-3031

Email

azukizaw@derma.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Azukizawa

Organization

Osaka University,Graduate School of Medicine

Division name

Department of Dermatology

Zip code


Address

2-2,Yamadaoka, Suita, 565-0871 JAPAN

TEL

06-6879-3031

Homepage URL


Email

azukizaw@derma.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University, Graduate School of Medicine
Department of Dermatology

Institute

Department

Personal name



Funding Source

Organization

Health and Labor, Sciences, Research Grants
Department of Dermatology, Hokkaido University

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 01 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

2012 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 03 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 12 Month 01 Day

Last modified on

2013 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011107


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name