UMIN-CTR Clinical Trial
| Recruitment status | Enrolling by invitation |
| Unique ID issued by UMIN | UMIN000007870 |
| Receipt No. | R000009254 |
| Scientific Title | Study of the relationship between pathophysiology of neurological disease including multiple sclerosis and function of LOTUS |
| Date of disclosure of the study information | 2012/05/02 |
| Last modified on | 2019/05/26 (Ver. 7) |
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| Basic information | ||
| Public title | Study of the relationship between pathophysiology of neurological disease including multiple sclerosis and function of LOTUS | |
| Acronym | Study of the relationship between pathophysiology of neurological disease including multiple sclerosis and function of LOTUS | |
| Scientific Title | Study of the relationship between pathophysiology of neurological disease including multiple sclerosis and function of LOTUS | |
| Scientific Title:Acronym | Study of the relationship between pathophysiology of neurological disease including multiple sclerosis and function of LOTUS | |
| Region |
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| Condition | ||
| Condition | multiple sclerosis(MS) and related disease of MS, other neurological diseases | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | The purpose of this study is to find the relationship between Pathophysiology of multiple sclerosis (MS) and its related disease by analyzing expression pattern and function of LOTUS, and to aim at developing a new biomarker and new therapy. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Detection or not, concentration and specificity of LOTUS in biological sample including cerebrospinal fluid and blood in patients with multiple sclerosis |
| Key secondary outcomes | |
| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Patients who fit into diagnostic criteria for multiple sclerosis and we have their cerebrospinal fluid or blood sample.
Neurological diseases except for multiple sclerosis |
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| Key exclusion criteria | none | |||
| Target sample size | 200 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | Yokohama City University school of medicine | ||||||
| Division name | Department of Neurology and stroke medicine | ||||||
| Zip code | |||||||
| Address | 3-9 Fukuura Kanazawa-ku Yokohama | ||||||
| TEL | 045-787-2800 | ||||||
| ftanak@yokohama-cu.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| Organization | Yokohama City University school of medicine | ||||||
| Division name | Department of Neurology and stroke medicine | ||||||
| Zip code | |||||||
| Address | 3-9 Fukuura Kanazawa-ku Yokohama | ||||||
| TEL | 045-787-2800 | ||||||
| Homepage URL | |||||||
| interferon1234@gmail.com | |||||||
| Sponsor | |
| Institute | Yokohama City University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Yokohama City University |
| 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 | |
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| 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 | |
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| Date of disclosure of the study information |
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| 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 |
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| Date of IRB | |||||||
| Anticipated trial start date |
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| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009254 |
