UMIN-CTR Clinical Trial

Public title

The study of ALS biomarker based on molecular dynamics of oxidative stress regulatory factor

Acronym

ALS biomarker research

Scientific Title

The study of ALS biomarker based on molecular dynamics of oxidative stress regulatory factor

Scientific Title:Acronym

ALS biomarker research

Region

Japan

Condition

Amyotrophic lateral sclerosis
Parkinson's disease
Multiple sclerosis
Healthy individuals

Classification by specialty

Neurology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The verification of the usefulness of oxidative stress regulatory factor as the ALS biomarker using blood sample from ALS patients

Basic objectives2

Others

Basic objectives -Others

In order to analyze whether quantitative alteration of oxidative stress regulatory factor is specific in ALS, blood sample from healthy individuals and patients with Parkinson's disease and multiple sclerosis as controls would be also analyzed.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Exploration of novel biomarker

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

71

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as having ALS and satisfying all of the following criteria.
1)ALS patients who are diagnosed by EL Escorial revised Airlie House criteria as clinically definite,clinically probable or clinically probable-laboratory-supported, clinically pssible ALS or clinically suspected ALS, and Stage I, II or III in ALS severity classification.
2)Older than 20 and younger than 71 years old
3)Patients who give informed consent after detailed explanation of the study

As disease controls, PD or MS patients satisfying all of the following criteria.
1)Older than 20 and younger than 71 years old
2)Patients who consulted a nerve outpatient and obtained consent for study entry
3)Patients who give informed consent after detailed explanation of the study

Healthy individuals satisfying all of the following criteria.
1)Older than 20 and younger than 71 years old
2)Healthy individuals who have interest in this study
3)Healthy individuals who give informed consent after detailed explanation of the study

Key exclusion criteria

1)Patient to whom the diagnosis has not been disclosed
2)Patient having severe psychiatric symptoms (hallucination, delusion) or dementia
3)Patient having serious orthostatic hypotension or other types of hypotension
4)Patient having a severe complication(s) such as heart, kidney and/or liver disease
5)Patient having the complications of the allergic disease that an acidophile level is easy to rise
6)Patient did not have ability to comprehend informed consent
7)Patient who was inappropriate for this study
8)Patient who has received an investigational drugs or devices within three months before
9) Patient who participates in other clinical trials
*The patient treated with existing therapeutic drug does not correspond to exclusion criteria

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Joh-E Ikeda

Organization

Faculty of Medicine, Kitasato University

Division name

Department of Molecular Neurology

Zip code

Address

1-15-1, Kitasato, Minami, Sagamihara, Kanagawa 252-0374, Japan

TEL

042-778-9441

Email

alspd@med.kitasato-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazunori Tanaka

Organization

Faculty of Medicine, Kitasato University

Division name

Department of Molecular Neurology

Zip code

Address

1-15-1, Kitasato, Minami, Sagamihara, Kanagawa 252-0374, Japan

TEL

042-778-9441

Homepage URL

Email

alspd@med.kitasato-u.ac.jp

Institute

Faculty of Medicine, Kitasato University

Institute

Department

Personal name

Organization

Faculty of Medicine, Kitasato University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

02

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

05

Month

27

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a prospective observational study to establish biomarker for disease progression in ALS. As control groups, healthy individuals, patients with Parkinson's disease and multiple sclerosis would be analyzed.

Registered date

2014

Year

02

Month

24

Day

Last modified on

2015

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015091