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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000018468 |
Receipt No. | R000020233 |
Scientific Title | Japanese Longitudinal Biomarker Study in PSP and CBD |
Date of disclosure of the study information | 2015/08/01 |
Last modified on | 2021/01/31 |
Basic information | ||
Public title | Japanese Longitudinal Biomarker Study in PSP and CBD | |
Acronym | Japanese Longitudinal Biomarker Study in PSP and CBD (JALPAC) | |
Scientific Title | Japanese Longitudinal Biomarker Study in PSP and CBD | |
Scientific Title:Acronym | Japanese Longitudinal Biomarker Study in PSP and CBD (JALPAC) | |
Region |
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Condition | ||||||
Condition | progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), corticobasal syndrome (CBS) | |||||
Classification by specialty |
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Classification by malignancy | Others | |||||
Genomic information | YES |
Objectives | |
Narrative objectives1 | The present project is a longitudinal observation study. The aims of the study are as follows. 1) To clarify natural history of patients with PSP/CBD syndrome, 2) To explore diagnostic and prognostic biomarker |
Basic objectives2 | Others |
Basic objectives -Others | Validation of published diagnostic criteria for Japanese patients with PSP/CBS |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | - Elucidation of the natural history
- Development of new biomarker(s) |
Key secondary outcomes | - Clinical evaluations including cognitive, language, oculomotor, and motor functions during the observation period.
- Clinical severity - MRI (volumetric analysis) - Known CSF and blood biomarkers - Neuropathological examination |
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 | |
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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 | 1) Patients 20 years of age or older who provide written informed consent
2) Healthy volunteers 20 years of age or older who provide written informed consent 3) Patients meeting the NINDS-SPSP diagnostic criteria (Litvan 1996) 4) Patients meeting the modified version of the Cambridge CBS diagnostic criteria (Mathew 2012) 5) Patients meeting the CBD diagnostic criteria (Armstrong 2013) 6) Patients who do not meet the diagnostic criteria of PSP/CBS, but clinically suspected as having these conditions |
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Key exclusion criteria | fulfill the diagnostic criteria of other neurodegenerative disorders | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Niigata University, Brain Research Institute | ||||||
Division name | Center for Bioresource | ||||||
Zip code | 951858 | ||||||
Address | 1-757 Asahimachi, Niigata 951-8585, Japan | ||||||
TEL | 025-227-2344 | ||||||
ikeuchi@bri.niigata-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Niigata University, Brain Research Institute | ||||||
Division name | Molecular Genetics | ||||||
Zip code | 951-8585 | ||||||
Address | 1-757 Asahimachi, Niigata 951-8585, Japan | ||||||
TEL | 025-227-2344 | ||||||
Homepage URL | |||||||
ikeuchi@bri.niigata-u.ac.jp |
Sponsor | |
Institute | Niigata University, Brain Research Institute |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Research Committee of CNS Degenerative Diseases |
Name of secondary funder(s) | MHLW (Japan) |
IRB Contact (For public release) | |
Organization | Research Ethics Committee |
Address | 1-754 Asahimachi, Niigata 951-8585, Niigata |
Tel | 025-227-2625 |
sanonao@adm.niigata-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 | 鳥取大学病院(鳥取県)/ Tottori University (Tottori),新潟大学医歯学総合病院(新潟県)/ Niigata University (Niigata),神戸大学病院(兵庫県)/ Kobe University (Hyogo),名古屋大学病院(愛知県)/ Nagoya University (Aichi),東京都立神経病院(東京都)/ Tokyo Metropolitan Neurological Hospital (Tokyo),自治医科大学病院(栃木県)/ Jichi Medical University (Tochigi),高知大学(高知県)/ Kochi University (Kochi),松江医療センター(島根県)/ Matsue Medical Center (Shimane),東名古屋病院(愛知県)/ East Nagoya National Hospital (Aichi),倉敷平成病院(岡山県)/ Kurashiki-Heisei Hospital (Okayama),三朝温泉病院(鳥取県)/ Misasa-Onsen Hospital (Tottori),群馬大学病院(群馬県)/ Gunma University (Gunma),京都府立医科大学病院(京都府)/ Kyoto Prefectural University of Medicine,東京都健康長寿医療センター病院(東京都)/ Tokyo Metropolitan Geriatric Hospital (Tokyo),相模原病院(神奈川県)/ Sagamihara National Hospital (Kanagawa),千葉東病院(千葉県)/ Chiba East National Hospital (Chiba),岡山旭東病院(岡山県)/ Okayama Kyokuto Hospital (Okayama),山梨大学(山梨県)/ Yamanashi University (Yamanashi),国立精神・神経研究センター(東京都)/ National Center Hospital NCNP (Tokyo),順天堂大学病院(東京都)/ Juntendo University (Tokyo),愛知医科大学病院(愛知県)/ Aichi Medical University (Aichi),徳島大学(徳島県)/ Tokushima University (Tokushima),ビハーラ花の里病院(広島県)/ Vihara Hananosato Hospital (Hiroshima),東京大学病院(東京都)/ University of Tokyo (Tokyo),老年病研究所病院(群馬県)/ Geriatric Disease Research Hospital (Gunma),三重大学病院(三重県)/ Mie University (Mie),千葉大学病院(千葉県)/ Chiba University (Chiba),順天堂大学越谷病院(埼玉県)/ Juntendo University Koshigaya Hospital (Saitama),東北大学病院(宮城県)/ Tohoku University (Miyagi),岡山大学病院(岡山県)/ Okayama University (Okayama),福岡大学病院(福岡県)/ Fukuoka University (Fukuoka),大阪大学病院(大阪府)/ Osaka University (Osaka),北海道大学病院(北海道)/ Hokkaido University,産業医科大学病院(福岡県)/ University of Occupational and Environmental Health (Fukuoka) / 東京医科歯科大学病院(東京)/ Tokyo Medical and Dental University,国立病院機構 兵庫中央病院 / Hyogo Central Hospital,東邦大学医療センター大森病院 / Toho University Medical Center Ohmori Hospital,国立病院機構 三重病院 / Mie Hospital,富士見高原病院 / Fujimi-Kogen Hospital,群馬大学 / Gunma University Hospital,岐阜大学 / Gifu University Hospital,国立病院機構 鈴鹿病院 / Suzuka Hospital,国立病院機構 新潟病院 / Niigata Hospital,山形大学 / Yamagata University Hospital,桑名総合医療センター / Kuwana General Medical Center,東邦大学医療センター佐倉病院 / Toho University Medical Center Sakura Hospital,福祉村病院 / Fukushimura Hospital |
Other administrative information | |||||||
Date of disclosure of the study information |
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URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Other related information | This study is a multicenter observational study in which case and control subjects will be recruited and longitudinally followed.
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Management information | |||||||
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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/ctr_e/ctr_view.cgi?recptno=R000020233 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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