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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012874
Receipt No. 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 2015/07/22

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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
Middle name
Last name Yoshihisa Yamano M.D.,Ph.D.
Organization Institute of Medical Science,
St. Marianna University School of Medicine
Division name Department of Rare Diseases Research
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL 044-977-8111(3155)
Email yyamano@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Yamano M.D.,Ph.D.
Organization Institute of Medical Science,St. Marianna University School of Medicine
Division name Department of Rare Diseases Research
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL 044-977-8111
Homepage URL
Email yyamano@marianna-u.ac.jp

Sponsor
Institute St. Marianna University
Institute
Department

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
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 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
Anticipated trial start date
2014 Year 01 Month 09 Day
Last follow-up date
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
2015 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.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


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