UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012874
Receipt number R000015038
Scientific Title Prospective multicenter clinical study on outcome measures for HTLV-1-associated myelopathy (HAM)
Date of disclosure of the study information 2014/01/16
Last modified on 2021/01/22 09:24:14

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Basic information

Public title

Prospective multicenter clinical study on outcome measures for HTLV-1-associated myelopathy (HAM)

Acronym

HAM-OM

Scientific Title

Prospective multicenter clinical study on outcome measures for HTLV-1-associated myelopathy (HAM)

Scientific Title:Acronym

HAM-OM

Region

Japan


Condition

Condition

HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

In order to develop outcome measures for evaluating HAM, data on candidate biomarkers and clinical parameters is gathered from multiple institutions, and biostatistical analysis is performed to evaluate the adequacy of the candidates as biomarkers and outcome measures. Prognostic biomarkers are identified by gathering HAM patient-derived bioresources before and after treatment, measuring the levels of prognostic biomarkers that have already been reported, analyzing with OMICS, and evaluating the degree of correlation between these levels and disease progression. Furthermore, changes in candidate biomarker levels due to treatment are analyzed to investigate their usefulness as surrogate/predictive biomarkers of treatment effectiveness.

Basic objectives2

Others

Basic objectives -Others

Search for prognostic biomarkers and clinical outcome measures

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Motor impairment severity, time for 10 meter walk, distance walked in 2 minutes
1) Blood and CSF<Blood>Serum concentrations of sIL-2R, CXCL10, and CXCL9; HTLV-1 proviral load in PBMCs
<CSF>Cell count, anti-HTLV-1 antibody titer, neopterin, CXCL9, CXCL10, CXCL13, HTLV-1 proviral load in cells in the CSF
2) Proteomic analysis of the plasma and CSF 3) Whole genomic analysis of PBMC-derived DNA, copy number variation analysis, peripheral blood RNA expression analysis

Key secondary outcomes

4) Treatment contents
5) QOL indicators


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients diagnosed with HAM according to the WHO guidelines (Kagoshima Science Council 1988)
2.The patient truly consents to participate in the study of his or her own free will (in the case of minors, requires consent of the legal guardian)

Key exclusion criteria

1. Patients with spinal cord compression lesion complications such as from cervical spine disease,intervertebral disc herniation, or yellow ligament ossification that affect gait assessment
2. Patients with knee or hip osteoarthritis, rheumatoid arthritis, or another musculoskeletal disease that affects gait assessment
3. Patients with Parkinsons disease or the aftereffects of stroke, cerebral hemorrhage, subarachnoid hemorrhage or other neurological disturbance affecting gait assessment
4. Serious complications that affect gait assessment (heart failure, respiratory dysfunction, renal failure, liver failure, etc.)
5. Patients with mental disorders such as dementia or neuropsychiatric diseases that affect ability to answer interview questions
6. Patients with any disease other than HAM for which they might be prescribed steroids (excluding topic medicines), interferon, or anti-cancer drugs
7. Patients with both severe anemia (hemoglobin less than 9.0 g/dl) and intracranial hypotension syndrome from whom it is deemed unwise with regard to the subjects safety to collect blood or CSF samples
8. Patients who have been deemed unfit for the study by a study investigator or physician.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Yoshihisa
Middle name
Last name Yamano

Organization

St. Marianna University School of Medicine

Division name

Division of Neurology, Department of Internal Medicine

Zip code

2168511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan

TEL

044-977-8111

Email

yyamano@marianna-u.ac.jp


Public contact

Name of contact person

1st name Yoshihisa
Middle name
Last name Yamano

Organization

St. Marianna University School of Medicine

Division name

Division of Neurology, Department of Internal Medicine

Zip code

2168511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan

TEL

044-977-8111

Homepage URL


Email

yyamano@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University

Institute

Department

Personal name



Funding Source

Organization

The Research on Measures for Intractable Diseases Project of the Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan

Tel

044-977-8111

Email

k-sienbu.mail@marianna-u.ac.jp


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

聖マリアンナ医科大学(神奈川県)
国立病院機構 北海道医療センター 神経内科(北海道)
東北大学病院 神経内科、多発性硬化症治療学寄付講座(宮城県)
京都府立医科大学附属北部医療センター(京都府)
京都府立医科大学大学院 神経内科学(京都府)
関西医科大学附属枚方病院(大阪府)
川崎医科大学病院 神経内科・微生物学(岡山県)
愛媛大学医学部附属病院 薬物療法・神経内科(愛媛県)
九州大学病院 神経内科(福岡県)
長崎大学病院 神経内科(長崎県)
大分県立病院 神経内科(大分県)
鹿児島大学大学院医歯学総合研究科神経病学講座 神経内科・老年病学分野(鹿児島県)
医療法人三州会 大勝病院 神経内科(鹿児島県)
琉球大学医学部付属病院 神経内科(沖縄県)
湘陽かしわ台病院(神奈川県)
やまのクリニック(鹿児島県)
霞が関アーバンクリニック(東京都)
岩手医科大学内科学講座 神経内科・老年科分野(岩手県)
福岡大学医学部 神経内科学(福岡県)
岩手県立大船渡病院 神経内科(岩手県)
岩手県立久慈病院 神経内科(岩手県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 16 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

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 21 Day

Date of IRB

2014 Year 01 Month 14 Day

Anticipated trial start date

2014 Year 01 Month 14 Day

Last follow-up date

2024 Year 01 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective multicenter clinical study


Management information

Registered date

2014 Year 01 Month 16 Day

Last modified on

2021 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name